A study of microalbuminuria in sepsis with reference to acute physiology and chronic health evaluation II score in patients admitted to a medical intensive care unit : Journal of Clinical and Scientific Research

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Original Article

A study of microalbuminuria in sepsis with reference to acute physiology and chronic health evaluation II score in patients admitted to a medical intensive care unit

Katyarmal, D. T.1; Bhargav, K. M.1; Ganesh, M.1; Manolasya, Venkat1,; Nimmanapalli, Harinidevi2; Sarma, K. V. S.1

Author Information
Journal of Clinical and Scientific Research 12(2):p 119-126, Apr–Jun 2023. | DOI: 10.4103/jcsr.jcsr_29_22
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Abstract

Background: 

Prediction of outcome of critically ill patients helps in early aggressive therapy, optimum resource allocation and counselling of the family. This study was conceived to assess the predictive value of microalbuminuria, which is an underutilised biomarker.

Methods: 

This was a longitudinal observational study conducted between March 2018 and June 2019 to assess microalbuminuria in patients with and without sepsis and to evaluate whether the degree of microalbuminuria could predict mortality in sepsis, and its association with to the acute physiology and chronic health evaluation II (APACHE II) score and the sequential organ failure assessment (SOFA) scores.

Results: 

Among the 105 patients studied, 56 (53.3%) were male. This included patients with sepsis (n = 51) and without-sepsis (n = 54). The mean APACHE II score in sepsis group was 11.5 ± 3.5, in non-sepsis group was 8.2 ± 3.7 and overall was 9.8 ± 4.0. SOFA score in sepsis group was 3.0 ± 1.5, in non-sepsis group was 1.19 ± 1.15 and overall was 2.0 ± 1.6. The mean albumin/creatinine ratio (ACR) 1 and ACR2 among survivors were 150.5 ± 95.2 and 152.2 ± 87.2 and among non-survivors were 230.9 ± 43.9 and 287.8 ± 8.70, respectively. ACR2 performed similar to APACHE II in predicting mortality (difference between areas = 0.239; standard error = 0.0593 [95% confidence intervals: 0.123–0.355]; P = 0.0001).

Conclusions: 

ACR2 had the highest value among ACR1, ACR2 and APACHE II for predicting mortality.

INTRODUCTION

In intensive care unit (ICU), prediction of outcome of patients is of vital importance. It helps in planning of early aggressive therapeutic interventions, optimum resource allocation and counselling of the family and/or patient. The two widely adopted systems to predict mortality and morbidity are the acute physiology and chronic health evaluation II (APACHE II)[1] and the simplified acute physiology score II (SAPS II) scores.[2] Although useful to evaluate the outcome, these tools are of limited use in day-to-day practice. Sensitive dynamic and inexpensive prognostic markers that generate rapid and reliable results are desirable in the ICU setting. Critical illnesses are often characterised by the systemic inflammatory response syndrome (SIRS), the host response to an acute insult. SIRS is a common finding in the ICU patients, which, when severe, can lead to multiple organ failure and finally death.[3] The gold standard for the diagnosis of sepsis is the isolation of causative organism in the culture of appropriate body fluids or tissue, which takes more than 24 h causing delay in the initiation of targeted therapy which in turn impacts the outcome. Hence, the search for early markers of sepsis still continues. Sepsis remains a major global healthcare concern, owing to high morbidity and mortality, despite the advances in medical therapeutics.[4] Targeted therapies probably lose their efficacy due to late administration.[5] Levels of microalbuminuria increase within hours of an inflammatory insult as compared to relatively delayed inductions of procalcitonin (PCT) and C-reactive protein (CRP).[6] Assay of the amount of albumin excreted in a random urine sample, expressed as albumin/creatinine ratio (ACR), is proven to be a simple, validated and reliable test.[7] Several studies in various groups of critically ill patients have established microalbuminuria as a significant prognostic marker of morbidity and mortality in the ICU.[8]

The primary objective of the present study is to assess whether there exists any significant difference between microalbuminuria levels between patients with sepsis and those without admitted to the medical ICU (MICU) and also to assess whether the change in microalbuminuria levels in the first 24 h could help predict the mortality and morbidity by comparing the microalbuminuria levels with APACHE II score.

Very few prognostic markers of sepsis are available, and those which are in use are either expensive or time taking. Especially in a developing country like India, utilisation of cost-effective prognostic markers to diagnose this life-threatening condition at the earliest can bring a major difference in the mortality rates. The microalbuminuria level is one such underutilised marker, on which very little data have been published. Majority of the data are available from Western countries, but presentation and outcomes in developing countries differ significantly from those in developed countries due to wide variations in the aetiologies and the available healthcare facilities. Moreover, scarce data are available, especially from South India. Hence, this study was conceived.

MATERIAL AND METHODS

Consecutive patients aged 18 years and above admitted to MICU with a stay period of more than 24 h at Sri Venkateswara Institute of Medical Sciences (SVIMS), Tirupati, a tertiary care teaching hospital, during the period from March 2018 to June 2019. They were included in the said study to assess the microalbuminuria levels in patients with sepsis and compare it with patients without sepsis and to evaluate whether the degree of microalbuminuria could predict mortality in sepsis, in relation to the APACHE II score and sequential organ failure assessment (SOFA) score. Patients less than 18 years, pregnant women, women were menstruating at the time of study, patients having anuria, macroscopic haematuria, urinary tract infection, pre-existing renal disease, seropositive for human immunodeficiency, nosocomial infection, and those who were not willing to participate in the study were excluded.

The study was initiated after obtaining clearance from the Institutional Ethics Committee, IEC No. 738 (Letter Roc. No. AS/11/IEC/SVIMS/2017). A written informed consent form was obtained from all patients participating in the study. In case the patient was unconscious or of poor sensorium, consent was obtained from a next responsible attendant.

On admission, a detailed history was taken and a thorough clinical examination was done. For disease severity scoring, APACHE II score[1] was calculated from the data collected during the first 24 h following ICU admission. Each patient was followed up throughout their ICU stay. The discharge from the ICU or mortality was considered as the outcome.

At the time of admission and again after 24 h, patients were examined for vital signs and symptoms of organ failure and/or infection. Clinical and laboratory data were collected. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)[9] were used to identify patients with sepsis and septic shock. On the basis of the above, patients were divided into two groups: patients without sepsis and patients with sepsis.

Spot urine samples were collected for quantification of albumin creatinine ratio (ACR), within 6 h of admission (ACR1) and again at 24 h (ACR2). Urinary microalbumin was measured by the immunoturbidimetric method and urinary creatinine by modified kinetic Jaffe reaction using Beckman Coulter AU 680 analyser (Japan). The methods cover an analytical range of 0.2–30 mg/dL for spot urine microalbumin and 25–400 mg/dL for spot urine creatinine. Microalbuminuria was defined as shown in Table 1.[10] Trend of microalbuminuria was assessed from the change of ACR value within 6 h of admission (ACR1) to the ACR value at 24 h (ACR2) in both groups of patients. For the prediction of mortality, APACHE II scores were compared with microalbuminuria levels based on receiver operating characteristic (ROC) curve analysis, with the area under curve (AUC) being the determining factor.

T1
Table 1:
Definition of microalbuminuria

Proteinuria was diagnosed by a dipstick test. Grading of proteinuria is shown in Table 2.[11] Urine protein values for microalbumin of >30 mg/day correspond to a detection level within the “trace” to “1+” range of a urine dipstick protein assay. Therefore, positive indication of any protein detected on urine dipstick assay obviates the need to perform a urine microalbumin test, as the upper limit for microalbuminuria had already been exceeded.

T2
Table 2:
Protein dipstick grading

In all patients, laboratory and imaging investigations were carried out for establishing a diagnosis and for managing the patient. Further, laboratory investigations required to compute the APACHE II score[1] were carried out. The laboratory investigations that were carried out include 1 peripheral venous blood sample (8 mL) for complete haemogram, serum creatinine, serum electrolytes, liver function tests, serum PCT and viral markers. One set of blood culture were sent at the time of admission. 1 mL of heparinised blood sample was procured for arterial blood gas (ABG) analysis from the radial artery and was transported to the laboratory immediately for processing. ABG analysis was done using AVL Compact 2 (Radiometer, Denmark) analyser. Urine was sent for routine and microscopy, spot urine microalbumin, spot urine creatinine and culture. Sputum or endotracheal tube aspirate was sent for examination and culture. Imaging investigations such as chest radiograph, computed tomography of the chest and ultrasonography of the abdomen were done wherever necessary.

Effective protocol-directed therapeutic interventions such as fluid resuscitation, antibiotics, inotrope and vasopressor use and tight glycaemic control were administered within the initial hours of ICU admission.[12] The degree of microalbuminuria after 24 h of ICU admission reflect the degree of ongoing endothelial dysfunction after goal-directed therapy.

Discharge from MICU or MICU mortality was considered as the end point for assessing the outcome. In worst case scenario analysis[13] left against medical advice (LAMA) patients were considered to have died.

Statistical analysis

The data were recorded on a pre-designed proforma and managed using Microsoft Excel 2007 (Microsoft Corp., Redmond, USA). To ensure consistency in measurement and interpretation, the information collected was meticulously double-checked for any possible error and physically verified by the corresponding author. Patients were followed up until death or discharge from the hospital to register their survival status, which was used as the primary end point.

Descriptive statistics were reported as mean ± standard deviation or median interquartile range as was applicable. Categorical variables are reported as percentages. Unpaired Student’s t-test was used for comparison of means between the two groups. Comparison of means within the group was done by paired Student’s t-test.

The ROC curves and interactive dot diagrams were used for calculating the optimal cut-off values of APACHE II score, ACR1 and ACR2 for predicting mortality. APACHE II scores were compared with microalbuminuria levels based on ROC curve analysis, with the AUC being the determining factor for predicting mortality. All P values were two-tailed; P < 0.05 was considered statistically significant. Discharge from MICU or MICU mortality was considered as the end point for assessing the outcome. In worst case scenario analysis[13] left against medical advice (LAMA) patients were considered to have died.

The statistical software IBM SPSS Statistics Version 20 (IBM Corp Somers NY, USA); Stata/IC 12 for Windows (StataCorp LP, Texas, USA); and MedCalc Version 11.3.0 for Windows 2000/XP/Vista/7 (MedCalc Software bvba, Belgium) were used for all mathematical computations and statistical calculations.

RESULTS

One hundred and twenty patients who were admitted in MICU at Sri Venkateswara Institute of Medical Sciences (SVIMS), Tirupati, from March 2018 to June 2019 were screened. Of these, 9 patients were excluded due to more than 1+ urine protein on dipstick, 4 patients were excluded due to CKD and 2 excluded due to duration of ICU stay <24 h. The remaining 105 patients were included in the study. These details are shown in Figure 1.

F1
Figure 1:
Study plan MICU = Medical intensive care unit; CKD = chronic kidney disease

Of the 105 patients included in the study, 56 (53.3%) patients were male. Their mean age was 56.0 ± 17.1 years. Patients were divided into sepsis group (n = 51)and non-sepsis group (n = 54). The mean APACHE II and SOFA scores in the sepsis and non-sepsis groups were 9.8 ± 4.0 and 2.0 ± 1.6, respectively. The mean APACHE II and SOFA scores in the sepsis group was 11.5 ± 3.5 and 3.0 ± 1.5 respectively. The mean APACHE II and SOFA scores of non-sepsis group were 8.2 ± 3.7 and 1.19 ± 1.15 respectively. The mean duration of ICU stay was 9.6 ± 5.3 days in the sepsis group and 5.8 ± 2.8 days in the non-sepsis group. The mean ACR1 and ACR2 values were 165.8 ± 93.2 and 178.1 ± 95, respectively. The mean ACR1 (in μg/mg) was 170.4 ± 90.8 the in sepsis group and 161.5 ± 96 in the non-sepsis group. The mean ACR2 was 206.0 ± 90.9 in the sepsis group and 151.7 ± 91.9 in the non-sepsis group. The change in microalbuminuria levels over a period of 24 h in the sepsis and non-sepsis groups is shown in Figure 2.

F2
Figure 2:
Mean change in ACR values over 24 hours among survivors and non-survivors ACR = Albumin-creatinine ratio

In the present study, 20 (19.0%) patients died and 85 (81%) survived. Seventeen were in the sepsis group and three in the non-sepsis group. The mean ACR1 values among survivors and non-survivors were 150.5 ± 95.2 and 230.9 ± 43.9, respectively (Figure 3). The mean ACR2 values among survivors and non-survivors were 152.2 ± 87.2 and 287.8 ± 8.70, respectively (Figure 4).

F3
Figure 3:
Interactive dot diagram for ACR1 observed among dead and alive patients. The horizontal line depicts the cut-off value ACR = albumin creatinine ratio; Sens = Sensitivity; Spec = Specificity
F4
Figure 4:
Interactive dot diagram for ACR2 observed among dead and alive patients. The horizontal line depicts the cut-off value ACR = Albumin creatinine ratio; Sens = Sensitivity; Spec = Specificity

The ROC curve for calculating the optimal cut-off value of APACHE II score for predicting death and the interactive dot diagram for APACHE II values are shown in Figures 5 and 6, respectively. The criterion values and coordinates of the ROC curve are shown in Table 3. At a cut-off value of APACHE II score ≥8, the sensitivity and specificity were 85.0 and 44.7, respectively. At a cut-off value of ACR1 ≥173 μg/mg, the sensitivity and specificity were 95.0 and 55.3, respectively. The interactive dot diagram for calculating the optimal cut-off value of ACR2 for predicting death. At a cut-off value of ACR2 ≥261 μg/mg, the sensitivity and specificity were 100.0 and 82.4, respectively.

F5
Figure 5:
ROC curve for calculating the cut-off value for APACHE II score to predict mortality. The area under the ROC curve (AUC) = 0.692; standard error = 0.059; 95% confidence intervals = 0.594 to 0.778; z-statistic = 3.252; significance level P (Area = 0.5) = 0.0011. ROC = Receiver operating characteristic curve, APACHE II = Acute Physiology and Chronic health evaluation II, AUC= Area under curve
F6
Figure 6:
Interactive dot diagram for APACHE II score observed among dead and alive patients. The horizontal line depicts the cut-off value APACHE II = Acute physiology and chronic health evaluation II
F7
Figure 7:
Comparison of performance of ROC curves of APACHE II score and microalbuminuria levels in predicting mortality Violet line= APACHE II; Green line = ACR1 (µg/mg); Orange line=ACR2 (µg/mg) ROC = Receiver operating characteristic curve, APACHE II = Acute Physiology and Chronic Health Evaluation II, ACR = Albumin creatinine ratio
T3
Table 3:
Comparison of performance of Acute Physiology and Chronic Health Evaluation II score and microalbuminuria levels in predicting mortality

Comparison of performance of APACHE II score and microalbuminuria levels in predicting mortality is shown in Table 3. ACR2 performed similar to APACHE II in predicting mortality (difference between areas = 0.239; SE = 0.0593 [95% confidence interval: 0.123–0.355]; z-statistic = 4.035; P = 0.0001).

DISCUSSION

Early diagnosis of sepsis is of vital importance for patient management and outcome, as early institution of appropriate therapy can be life-saving for the patient. Of the many markers of sepsis available, PCT was considered specific and sensitive in identifying systemic bacterial infections; it has certain limitations such as increases in several non-infectious inflammatory conditions and absence of increase in localised infections.[14,15] CRP is another marker of sepsis, which has limitations of low specificity for the diagnosis of sepsis, slow induction time and lack of correlation with severity of disease, even though it is cheaper.[16,17]

The levels of microalbuminuria start increasing within hours of an inflammatory insult as against delayed increase in levels of CRP and PCT.[6] Sparse published data are available regarding biomarkers of sepsis from developing countries like India. In India, utilisation of cost-effective prognostic markers to diagnose this life-threatening condition at the earliest can bring a major difference in the mortality rates. Majority of the data are available from Western countries, but presentation and outcomes in developing countries differ significantly from those in developed countries due to wide variations in the aetiologies and the available healthcare facilities.

Comparing age distribution in the present study with the studies done in India and other parts of world,[18–22] showed age distribution in the present study to be similar. In comparison of gender distribution in the present study with the studies done in India and other parts of world, the male: female ration ranged from 1.21:1 to 2.63:1. In our study, the male: female ratio was 1.14:1.[18–22] Overall men outnumbered women (53.3%). In Tirupati and the Rayalaseema area, which is predominantly rural where the present study was carried out, traditionally men seek and receive medical attention earlier compared to females who still are denied the basic medical facilities. Another reason for male predominance could be that as men tend to stay outdoors, and in overcrowded places for work, they are at a higher risk of exposure to a wide variety of infectious agents and subsequent hospital admission. A similar demographic trend was evident in other published studies from India and other world studies. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) were used to delineate patients with sepsis.[9] On the basis of the above, patients were divided into two groups: patients without sepsis and patients with sepsis. In the both groups, patients were comparable with respect to demographic parameters.

Among sepsis group, 13 patients had diabetes mellitus (DM), 10 patients had hypertension (HTN) and 18 patients had chronic obstructive airway disease (COPD). A study[4] showed that COPD was the most common underlying co-morbidity, which was present in 12.3% of the patients. This shows that lung is the most common source of infection, leading to sepsis. Among non-sepsis group, 8 patients had DM, 6 had HTN and 2 had ischaemic heart disease.

Urine for ACR was collected within 6 h (urine ACR1) and within 48 h of admission (urine ACR2). In the present study, urine ACR1 ranged from 31.2 μg/mg to 296.9 mg/mg with a mean of 165.8 ± 93.2. Urine ACR1 differed significantly among survivors and non-survivors. Patients who survived had a mean ACR1 of 150.5 mg/mg and patients who died had ACR1 of 230.9 mg/mg (P = 0.0001). The levels of microalbuminuria were significantly high among those with sepsis at admission as compared to the patients without sepsis. These levels continued to remain significantly high among the non-survivors, whereas they had dropped among those who survived. This was similar to data reported some studies[18,20,22] published recently. In our study, the value in survivors was 150.5 and in non-survivors it was 230.9 (P = 0.0001). The effect of the inflammatory cascade, which occurs in response to sepsis, will damage the endothelium of the capillaries, along with damage to the glycocalyx layer of the endothelium which normally acts as a barrier against passage of albumin across the capillary wall. Damage to the glycocalyx results in increased permeability of the capillaries with loss of albumin.[18] In the present study, patients who survived had a mean ACR2 of 152.2 ± 87.2 mg/mg and patients who died had ACR2 of 287.8 ± 8.70 mg/mg (P = 0.001). This was similar to some published studies.[18,20,22] Also, in our study, the microalbuminuria levels after 24 h were found to decrease significantly among the patients without sepsis as compared to the patients with sepsis. The decrease in levels after 24 h of MICU admission might be the result of the decrease in the inflammatory processes occurring due to the treatment. The initiation of early and effective treatment might help protect the glycocalyx layer and prevent further increase in capillary permeability. On the basis of the above observations, it could be said that microalbuminuria has a discriminatory role in the diagnosis of sepsis and also to check the effect of treatment. Microalbuminuria was used as a marker to document the effect of treatment of high doses of N-acetyl cysteine, an antioxidant and low-dose hydrocortisone, respectively, in severe clinical sepsis.[23,24]

In the present study 19% patients had died. This is consistent with various studies[18–21,25–27] which showed mortality ranging from 20% to 35%. A study[25] showed case fatality increased linearly with age and age was an independent predictor of mortality. Among the patients who died 20 (19%), 13 had an infectious source in the lung. Other causes included catheter-associated blood stream infection and urinary tract infections. A study[4] showed that women had less age-specific incidence and mortality rates in comparison to men. The study[4] also showed that 44% of the mortality was due to respiratory source of infection, 17.3% had bacteraemia from an unidentified source, 8.6% had an abdominal source and 6.6% had local wound as a source of infection.

At a cut-off value of APACHE II score ≥8, the sensitivity and specificity were 85.0 and 44.7, respectively for predicting death. At a cut-off value of ACR1 ≥173 μg/mg, the sensitivity and specificity were 95.0 and 55.3, respectively. At a cut-off value of ACR2 ≥261 μg/mg, the sensitivity and specificity were 100.0 and 82.4, respectively for predicting death.

The present study has demonstrated that the area under the ROC curves for prediction of mortality was highest for ACR2 (0.931), followed by ACR1 (0.719) and APACHE II (0.692) (Table 3). A study[21] found that ACR1 was as good as APACHE II in predicting mortality among surgical patients but not in the medical patients. Another study[18] had found that ACR2 was as good as APACHE II for mortality prediction. Thus, in the present study, ACR2 has the highest value among ACR1, ACR2 and APACHE II for predicting mortality. However, in the present study, ACR2 has performed significantly better than APACHE II as the AUC was significantly higher for ACR2. The finding of ACR2 as a better predictor of mortality could be explained due to the presence of ongoing inflammatory processes among those who died and hence the higher levels of ACR2 among them. On the other hand, a lower level of ACR2 among survivors might indicate decrease in the inflammatory activity and explain the improved survival. A study[28] had also found a higher mortality among patients with increasing microalbuminuria levels. Microalbuminuria has been reported to be a good tool/marker in the prediction of mortality.[8] Microalbuminuria is a non-invasive and inexpensive bedside screening test to identify the patients having sepsis (positive predictive value [PPV 88%]). The sensitivity (93%) and specificity (71%) of the 6th hour ACR in differentiating the infected individuals from uninfected patients is comparable to that of sensitivity and specificity of procalcitonin (85% and 83%) and C-reactive proten (69% and 61%) respectively.[22] The ACR test results can be made available as early as 30 min. The ACR can also be estimated by the ICU nurses within a short time of 15 min.[29]

The present study was a single-centre study and was carried out over a limited period of time. Many conditions such as age (>40 years), smoking, alcohol, body mass index (BMI), DM and HTN are the independent causes of microalbuminuria in the general population.

The present study has demonstrated that the area under the ROC curves for prediction of mortality was highest for ACR2 (0.931), followed by ACR1 (0.719) and APACHE II (0.692). In the present study, ACR2 had the highest value among ACR1, ACR2 and APACHE II for predicting mortality. However, in the present study, ACR2 had performed significantly better than APACHE II as the AUC was significantly higher for ACR2.

Several potential applications of microalbuminuria measurement in the critically ill were suggested by this study. The present data gives an insight into early recognition of sepsis with the help of microalbuminuria as a biomarker and also in predicting mortality in South India patients admitted to the MICU. The 24-hour ACR assessment predicts ICU survival and may have the potential to monitor the efficacy of therapeutic interventions delivered.

Financial support and sponsorship

The study was funded by the Sri Balaji Arogya Varaprasadini Scheme of the Sri Venkateswara Institute of Medical Sciences, Tirupati and Tirumala Tirupati Devasthanams Tirupati (Grant No. SBAVP-RG/MD/72).

Conflicts of interest

The authors are faculty members/residents of Sri Venkateswara Institute of Medical sciences, Tirupati, of which Journal of Clinical and Scientific Research is the official Publication. The article was subject to the journal’s standard procedures, with peer review handled independently of these faculty and their research groups.

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Keywords:

Acute Physiology and Chronic Health Evaluation II; microalbuminuria; mortality; predictor; sepsis

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