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Clinical Trial Comparing Continuous Versus Intermittent Hemodialysis in ICU Patients (CONVINT)

Primary Purpose

Acute Renal Failure

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
RRT for acute kidney failure using the CVVH method
RRT for acute kidney failure using the IHD (intermittent HD)
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Renal Failure

Eligibility Criteria

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

Inclusion Criteria:

  • all ICU patients requiring renal replacement therapy

Exclusion Criteria:

  • patient denies informed consent
  • patient not requiring intensive care therapy
  • kidney transplanted patients
  • chronic renal failure (serum creatinine > 3mg/dl)

Sites / Locations

  • Charite University Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CVVH arm

IHD arm

Arm Description

Outcomes

Primary Outcome Measures

Survival at 2 weeks after RRT

Secondary Outcome Measures

Full Information

First Posted
October 25, 2010
Last Updated
May 23, 2011
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01228123
Brief Title
Clinical Trial Comparing Continuous Versus Intermittent Hemodialysis in ICU Patients
Acronym
CONVINT
Official Title
Prospective Randomised Clinical Trial of the Effect of Continuous Versus Intermittent Renal Replacement Therapy on the Mortality and Outcome of Acute Renal Failure in ICU Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The mortality of acute renal failure (ARF) remains to be high (around 60-70%) despite manifold improvements in ICU care. At present, it is not clear if the method chosen for renal replacement therapy, i.e. intermittent haemodialysis (IHD) or continuous haemofiltration (CVVH), might impact on the outcome of these patients. For this purpose, a prospective randomised clinical study of the effect of continuous versus intermittent renal replacement therapy on the mortality and outcome of acute renal failure will be performed.
Detailed Description
please see above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CVVH arm
Arm Type
Active Comparator
Arm Title
IHD arm
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
RRT for acute kidney failure using the CVVH method
Other Intervention Name(s)
does not apply
Intervention Description
patients randomized to receive CVVH
Intervention Type
Other
Intervention Name(s)
RRT for acute kidney failure using the IHD (intermittent HD)
Other Intervention Name(s)
does not apply
Intervention Description
patients randomized to receive IHD
Primary Outcome Measure Information:
Title
Survival at 2 weeks after RRT
Time Frame
2 weeks after RRT in follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all ICU patients requiring renal replacement therapy Exclusion Criteria: patient denies informed consent patient not requiring intensive care therapy kidney transplanted patients chronic renal failure (serum creatinine > 3mg/dl)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Achim Joerres, MD
Organizational Affiliation
Charite University Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite University Medicine
City
Berlin
ZIP/Postal Code
13353
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
34519356
Citation
Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.
Results Reference
derived
PubMed Identifier
24405734
Citation
Schefold JC, von Haehling S, Pschowski R, Bender T, Berkmann C, Briegel S, Hasper D, Jorres A. The effect of continuous versus intermittent renal replacement therapy on the outcome of critically ill patients with acute renal failure (CONVINT): a prospective randomized controlled trial. Crit Care. 2014 Jan 10;18(1):R11. doi: 10.1186/cc13188.
Results Reference
derived

Learn more about this trial

Clinical Trial Comparing Continuous Versus Intermittent Hemodialysis in ICU Patients

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