NCT00322530

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

August 24, 2012

Status Verified

August 1, 2012

Enrollment Period

2.7 years

First QC Date

May 4, 2006

Last Update Submit

August 23, 2012

Conditions

DialysisAcute Renal Failure

Outcome Measures

Primary Outcomes (1)

  • Death

    90 days

Secondary Outcomes (5)

  • costs

    in hospital

  • Restitution of renal function

    90 days

  • days on ICU

    in hospital

  • hemodynamic stability

    in hospital

  • dialysis efficiency

    in hospital

Study Arms (2)

SLED

ACTIVE COMPARATOR
Procedure: Renal replacement therapy

CVVHD

ACTIVE COMPARATOR
Procedure: Renal replacement therapy

Interventions

Renal replacement therapyPROCEDURE

ICU patients with acute renal failure were prospectively randomized to either CVVHD or SLED

Also known as: sustained low efficiency dialysis (SLED), continous veno-venous hemodiafiltration (CVVHD)
CVVHDSLED

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Nephrology, University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (3)

  • 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.

    PMID: 36416787DERIVED

  • 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.

    PMID: 34519356DERIVED

  • Schwenger V, Weigand MA, Hoffmann O, Dikow R, Kihm LP, Seckinger J, Miftari N, Schaier M, Hofer S, Haar C, Nawroth PP, Zeier M, Martin E, Morath C. Sustained low efficiency dialysis using a single-pass batch system in acute kidney injury - a randomized interventional trial: the REnal Replacement Therapy Study in Intensive Care Unit PatiEnts. Crit Care. 2012 Jul 27;16(4):R140. doi: 10.1186/cc11445.

    PMID: 22839577DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Renal Replacement TherapyHybrid Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Vedat Schwenger, MD

    Division of Nephrology, University of Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

May 4, 2006

First Posted

May 8, 2006

Study Start

April 1, 2006

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

August 24, 2012

Record last verified: 2012-08

Locations

DE(1)