Early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury (ELAIN-Trial)

Early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury (ELAIN-Trial) - ELAIN

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004367

Enrollment

250

Registered

2013-05-28

Start date

2013-08-02

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N17

Interventions

Group 1: Early initiation of renal replacement therapy (stage 2 of the AKIN classification) Group 2: Late initiation of renal replacement therapy (stage 3 of the AKIN classification or absolute indica

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Overall survival in a 90-day follow up period (90-day all cause mortality)	—

Secondary

Measure	Time frame
- Length of ICU stay - length of hospitalization - duration of renal replacement therapy - recovery of renal function by day 28 - 60-day and 1-year all cause mortality - SOFA scores at day 1-14, 21 and 28 - requirement for hemodialysis after day 60 - cost analysis of renal replacement therapy - incidence of complication due to renal replacement therapy	—

Countries

Germany

Contacts

Public ContactCarola Wempe

Universitätsklinikum Münster Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie

wempe-c@anit.uni-muenster.de02518347267

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 13, 2026