The Hannover-Dialysis-Outcome (HAN-D-OUT)-Study: Comparison of Standard Versus Intensified Extended Dialysis in Treatment of Patients With Acute Kidney Injury in the Intensive-Care Unit
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Hannover Medical School
- Enrollment
- 157
- Locations
- 2
- Primary Endpoint
- Survival
Study Overview
Brief Summary
Mortality rates of patients with acute kidney injury in the intensive care unit have changed little over the past few decades despite significant advances in supportive care. Few interventions have been shown to result in an improvement of in-hospital mortality of these patients, with dose of renal replacement therapy (RRT) being one of the most important. Patients undergoing continuous veno-venous hemofiltration had better outcomes with ultrafiltration rates of 35 mL/kg/h or 45 mL/kg/h than those treated at a rate of 20 mL/kg/h. In a different trial, intermittent hemodialysis on a daily basis resulted in better control of uremia, fewer hypotensive episodes during dialysis, and more rapid resolution of acute renal failure than thrice weekly hemodialysis. In the present study we examine survival and renal recovery in critically ill patients with acute kidney injury that are treated with a currently recommended (standard) dose of RRT, and patients that receive intensified RRT.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •non post-renal AKI with RRT dependency indicated by oliguria/anuria <30mL/h >6 hours prior to inclusion
- •loss of kidney function of >30% within 48 hours prior to inclusion
- •hyperkalemia >6.5 mmol/L
- •severe acidosis with pH<7.15
Exclusion Criteria
- •pre-existing chronic kidney disease (CKD) as defined by an estimated glomerular filtration rate <50mL/min or a plasma creatinine concentration >1.7 mg/dL (>150 µmol/L) more than 10 days prior to initiation of the first RRT
- •presence of AV-fistula or dialysis catheter
- •participation in another study
- •consent denial or withdrawal
- •need for extra corporal membrane oxygenation therapy.
Outcomes
Primary Outcomes
Survival
Time Frame: Day 14 after initiation of renal replacement therapy
Secondary Outcomes
- Survival and renal recovery(Day 28 after initiation of renal replacement therapy)