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Hannover Dialysis Outcome Study (HAND-OUT)

Primary Purpose

Acute Kidney Failure

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Standard extended dialysis
Intensified extended dialysis
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Failure focused on measuring Extended dialysis, Acute kidney injury, Intensive care unit, Renal replacement therapy, Survival, Dialysis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hannover Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

Survival and renal recovery

Full Information

First Posted
September 13, 2007
Last Updated
September 14, 2007
Sponsor
Hannover Medical School
Collaborators
Fresenius AG
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1. Study Identification

Unique Protocol Identification Number
NCT00529139
Brief Title
Hannover Dialysis Outcome Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hannover Medical School
Collaborators
Fresenius AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Failure
Keywords
Extended dialysis, Acute kidney injury, Intensive care unit, Renal replacement therapy, Survival, Dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Standard extended dialysis
Intervention Description
Standard extended dialysis dosed to maintain plasma urea levels between 120-150 mg/dL (20 -25 mmol/L)
Intervention Type
Device
Intervention Name(s)
Intensified extended dialysis
Intervention Description
Intensified extended dialysis dosed to maintain near-normal plasma urea levels, i.e. <90 mg/dL (<15 mmol/L)
Primary Outcome Measure Information:
Title
Survival
Time Frame
Day 14 after initiation of renal replacement therapy
Secondary Outcome Measure Information:
Title
Survival and renal recovery
Time Frame
Day 28 after initiation of renal replacement therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danilo Fliser, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hannover Medical School
City
Hannover
ZIP/Postal Code
30625
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25855898
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.
Results Reference
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Hannover Dialysis Outcome Study

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