Hannover Dialysis Outcome Study

Acute Kidney Failure Clinical Trial

— HAND-OUT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529139
• Other study ID #: MHH - SLED - 01
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2007
• Last updated: September 14, 2007
• Start date: July 2003
• Est. completion date: May 2006

Study information

• Verified date: September 2007
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Failure
• Acute Kidney Injury
• Renal Insufficiency

Intervention

Device:
• Standard extended dialysis
Standard extended dialysis dosed to maintain plasma urea levels between 120-150 mg/dL (20 -25 mmol/L)
• Intensified extended dialysis
Intensified extended dialysis dosed to maintain near-normal plasma urea levels, i.e. <90 mg/dL (<15 mmol/L)

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	Fresenius AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		Day 14 after initiation of renal replacement therapy
Secondary	Survival and renal recovery		Day 28 after initiation of renal replacement therapy