Comparison of Dialysis Strategies in Critically Ill Patie... | NCT00322530

Studies
Comparison of Dialysis Strategies in Critically Ill Patients With Acute Renal Failure

NCT00322530

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

Aug 24, 2012Estimated

Enrollment

230Actual

Phase

Not Applicable

Conditions

Dialysis
Acute Renal Failure

Interventions

Renal replacement therapy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Dec 2008Actual

Completion Date

Feb 2009Actual

First Submitted Date

May 4, 2006

First Submission Date that Met QC Criteria

May 4, 2006

First Posted Date

May 8, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2012

Last Update Posted Date

Aug 24, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of the present study is the comparison of different dialysis strategies in critically ill patients with acute renal failure on the intensive care unit. Patients are treated with either continuous dialysis or hemofiltration. Outcome measures are death, restitution of renal function, days on ICU, hemodynamic stability, dialysis efficiency.

Detailed Description

The goal of the present study is the comparison of different renal replacement strategies in critically ill patients with acute renal failure on the intensive care unit. In a prospectively randomized clinical study patients are treated with either continuous dialysis (SLED) or continuous hemofiltration (CVVHD). 200 patients should be included in the study (n=100 each). The primary outcome is death at ICU, secondary outcome measures are restitution of renal function, days on ICU, hemodynamic stability, dialysis efficiency.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

230Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SLED	Active Comparator		Procedure: Renal replacement therapy
CVVHD	Active Comparator		Procedure: Renal replacement therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Renal replacement therapy	Procedure	ICU patients with acute renal failure were prospectively randomized to either CVVHD or SLED	CVVHD SLED

Measure	Description	Time Frame
Death		90 days

Measure	Description	Time Frame
costs		in hospital
Restitution of renal function		90 days
days on ICU

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18 years or older
Written informed consent
No pre-existing dialysis dependency

Exclusion Criteria:

Minors / children
No consent
Severe electrolyte disturbances which necessitates special dialysis therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vedat Schwenger, MD	Division of Nephrology, University of Heidelberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Nephrology, University of Heidelberg		Heidelberg	Baden-Wurttemberg	69120	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36416787	Derived	Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.
34519356	Derived	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.

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

ID	Term
D017582	Renal Replacement Therapy
D000079782	Hybrid Renal Replacement Therapy

ID	Term
D013812	Therapeutics
D005112	Extracorporeal Circulation
D013514	Surgical Procedures, Operative