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Hannover Dialysis Outcome Study (HAND-OUT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00529139
Recruitment Status : Completed
First Posted : September 14, 2007
Last Update Posted : September 17, 2007
Fresenius AG
Information provided by:
Hannover Medical School

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.

Condition or disease Intervention/treatment Phase
Acute Kidney Failure Device: Standard extended dialysis Device: Intensified extended dialysis Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2003
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
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)

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00529139

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Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Fresenius AG
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Principal Investigator: Danilo Fliser, MD Hannover Medical School
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00529139    
Other Study ID Numbers: MHH - SLED - 01
First Posted: September 14, 2007    Key Record Dates
Last Update Posted: September 17, 2007
Last Verified: September 2007
Keywords provided by Hannover Medical School:
Extended dialysis
Acute kidney injury
Intensive care unit
Renal replacement therapy
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases