Invitation for InSEA project


Epidemiology and Long termOutcome of Critically Ill Patients Requiring Renal Replacement Therapy

in India and Southeast Asia

(InSEA-RRT Registry)



Research Question:

Primary research question

1. In critically ill patients requiring RRT, is CRRT associated with better long term renal recovery compared to intermittent hemodialysis over a 2-year period?



Study Background & Rationale:


Acute kidney injury (AKI) is one of the most common and important problems in intensive care unit (ICU) patients. The incidence of AKI in ICU varies from 20% to as much as 50%. AKI plays an important role in patients’ morbidity and mortality. AKI associated hospital mortality rate in ICU patients ranged from 20% to 50% and may reach 60% if the patients required renal replacement therapy (RRT). Not only hospital mortality, AKI patients also have greater relative risk of death and cardiovascular events in long term follow up. The differences in incidence and outcome of AKI may be attributed to the criteria for AKI diagnosis, the population, and the centers studied. 

Although the standard criteria for diagnosis of AKI have been established for more than 10 years. The incidence and outcome of severe AKI in the large clinical scale in Southeast Asia (SEA) and India region, a sub-region of ASIA, which comprises of more than 1800 million people, have never been reported. Moreover, recent meta-analysis reported the world incidence of AKI without the data from SEA region.  In Thailand, we have at least five large cohort of chronic kidney disease (CKD) studiesbut having only small single center study for AKI.Studying the acute RRT epidemiology in multicenter level will help to complete the missing piece of kidney disease global epidemiology.

Recent data showed that CKD is another consequence of AKI. Coca et al reported the incidence rate of CKD after AKI episode to be as much as 7.8 per 100 patient years. The data of renal recovery will be one of the most important step in linking the process of AKI progression to CKD in Southeast Asia and India.

The present prospective observational study is conducted to determine the incidence and outcome (both short and long term) among severe AKI patients in Southeast Asia and India, and to analyze the factors that might impact the RRT incidence and outcome.


Principal Investigator



Name (First, Last)

Nattachai Srisawat



Assistant Professor



Chulalongkorn University


Address/Department City/State/Prov. Postal Code/Country

Department of Medicine, Faculty of Medicine, Bangkok, Thailand


















Primary Endpoint:

The effect of RRT modality on 2-year survival and renal recovery in critically ill patients requiring RRT in Southeast Asia and India.


Efficacy Assessments


Severe AKI patients (AKI stage 3 by KDIGO 2012 criteria) will be recruited in to study. We will collect the data by registration in electronic web-based format. Demographic, clinical and laboratorial data will be recorded. Demographic data will include age, gender, timing of hospital and ICU admission, co-morbidity disease and primary diagnosis at ICU admission.

Clinical data included Acute Physiology and Chronic Health Evaluation (APACHE) II score at ICU admission, Sequential Organ Failure Assessment (SOFA) scores for the first day, fluid balance status, the use of mechanical ventilator, vasopressor and RRT. Laboratory data included blood urea nitrogen and serum creatinine if available. The data will be serially collected every day for the first 7 days and then weekly collected on day 14, 21 and 28. The primary outcome is composite renal outcome (mortality, kidney function, and RRT status) at 2 year after ICU admission, and secondary outcomes are hospital mortality, RRT incidence, ICU mortality, length of stay, total mechanical ventilator days, and RRT days in ICU.



Duration of subject participation:

2 year

Total number of subjects to be enrolled:

We plan to enroll 10,000 cases for the cohort




Number of Sites:

Facility / Institution Name


Division of Nephrology, Faculty of Medicine, Chulalongkorn University & Excellence Center for Critical Care Nephrology, Thai Red Cross, King Chulalongkorn Memorial Hospital


10 centers


5 centers


5 centers


5 centers


5 centers


5 centers


5 centers



Statistical Methods (for analyzing primary & secondary endpoints):


The data will be analyzed using SAS program. Categorical data will bepresented as number and percentage. Continuous data will be presented as mean and standard deviation (SD) if normally distributed or median and interquartile range (IQR) if non-normal distributed. The Chi-square test will be used for the comparison of proportion (risk factors of RRT and hospital mortality in RRT and non RRT patients). The Student’s t test andMann Whitney U test are used for the comparison of mean and median, respectively. Multiple logistic regression is used for assessment the adjusted risk for RRT incidence and RRT associated mortality. A P value of less than 0.05 is considered to be significant.




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