Clinical trial NCT00529139: Hannover Dialysis Outcome Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Kidney Failure
Keywords: Extended dialysis
Acute kidney injury
Intensive care unit
Renal replacement therapy
Survival
Dialysis
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Fresenius AG
First posted: 2007-09-14
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Survival
timeFrame: Day 14 after initiation of renal replacement therapy
Secondary outcomes:
measure: Survival and renal recovery
timeFrame: Day 28 after initiation of renal replacement therapy
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Danilo Fliser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghosh CC, Thamm K, Berghelli AV, Schrimpf C, Maski MR, Abid T, Milam KE, Rajakumar A, Santel A, Kielstein JT, Ahmed A, Thickett D, Wang K, Chase M, Donnino MW, Aird WC, Haller H, David S, Parikh SM. Drug Repurposing Screen Identifies Foxo1-Dependent Angiopoietin-2 Regulation in Sepsis. Crit Care Med. 2015 Jul;43(7):e230-40. doi: 10.1097/CCM.0000000000000993.