Early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury (ELAIN-Trial)
- Conditions
- N17Acute renal failure
- Registration Number
- DRKS00004367
- Lead Sponsor
- niversitätsklinikum Münster
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 231
1. AKI: stage 2 of AKIN classification despite optimal resuscitation
2. plasma Neutrophil Gelatinase-Associated Lipocalin (NGAL) > 150 ng/ml
3. at least one of the following conditions (severe sepsis, use of catecholamines > 0.1 µ/kg/min; refractory fluid overload; development or progression of non-renal organ-dysfunction (SOFA >=2))
4. age between 18 and 90 yrs
5. intention to provide full intensive care treatment for at least 3 days
6. existence of informed consent
1) Patients with pre-existing kidney disease not requiring RRT (GFR < 30ml/min);
2) Patients who had received any previous renal-replacement therapy;
3) AKI caused by permanent occlusion or surgical lesion of the renal artery;
4) AKI caused by (glomerulo)nephritis, interstitial nephritis, or vasculitis;
5) AKI caused by postrenal obstruction;
6) hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura;
7) pregnancy;
8) prior kidney transplant;
9) hepatorenal syndrome;
10) AIDS with a CD4 count of <0.05 x 10E9/l;
11) hematologic malignancy with neutrophils of < 0.05 x 10E9/l; and
12) no hemofiltration machine free for use at the moment of inclusion
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival in a 90-day follow up period (90-day all cause mortality)
- Secondary Outcome Measures
Name Time Method - Length of ICU stay<br>- length of hospitalization<br>- duration of renal replacement therapy<br>- recovery of renal function by day 28<br>- 60-day and 1-year all cause mortality<br>- SOFA scores at day 1-14, 21 and 28<br>- requirement for hemodialysis after day 60<br>- cost analysis of renal replacement therapy<br>- incidence of complication due to renal replacement therapy