Hannover Dialysis Outcome Study (HAND-OUT)

This study has been completed.
Sponsor:
Collaborator:
Fresenius AG
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00529139
First received: September 13, 2007
Last updated: September 14, 2007
Last verified: September 2007
  Purpose

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.


Condition Intervention Phase
Acute Kidney Failure
Device: Standard extended dialysis
Device: Intensified extended dialysis
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Survival [ Time Frame: Day 14 after initiation of renal replacement therapy ]

Secondary Outcome Measures:
  • Survival and renal recovery [ Time Frame: Day 28 after initiation of renal replacement therapy ]

Enrollment: 157
Study Start Date: July 2003
Study Completion Date: May 2006
Arms Assigned Interventions
Active Comparator: A Device: Standard extended dialysis
Standard extended dialysis dosed to maintain plasma urea levels between 120-150 mg/dL (20 -25 mmol/L)
Active Comparator: B Device: Intensified extended dialysis
Intensified extended dialysis dosed to maintain near-normal plasma urea levels, i.e. <90 mg/dL (<15 mmol/L)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00529139

Locations
Germany
Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Fresenius AG
Investigators
Principal Investigator: Danilo Fliser, MD Hannover Medical School
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00529139     History of Changes
Other Study ID Numbers: MHH - SLED - 01
Study First Received: September 13, 2007
Last Updated: September 14, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by Hannover Medical School:
Extended dialysis
Acute kidney injury
Intensive care unit
Renal replacement therapy
Survival
Dialysis

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 29, 2014