NCT00529139

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2003

Typical duration for phase_4

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

July 1, 2003

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
Last Updated

September 17, 2007

Status Verified

September 1, 2007

First QC Date

September 13, 2007

Last Update Submit

September 14, 2007

Conditions

Acute Kidney Failure

Keywords

Extended dialysisAcute kidney injuryIntensive care unitRenal replacement therapySurvivalDialysis

Outcome Measures

Primary Outcomes (1)

  • Survival

    Day 14 after initiation of renal replacement therapy

Secondary Outcomes (1)

  • Survival and renal recovery

    Day 28 after initiation of renal replacement therapy

Study Arms (2)

A

ACTIVE COMPARATOR
Device: Standard extended dialysis

B

ACTIVE COMPARATOR
Device: Intensified extended dialysis

Interventions

Standard extended dialysisDEVICE

Standard extended dialysis dosed to maintain plasma urea levels between 120-150 mg/dL (20 -25 mmol/L)

A
Intensified extended dialysisDEVICE

Intensified extended dialysis dosed to maintain near-normal plasma urea levels, i.e. \<90 mg/dL (\<15 mmol/L)

B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hyperkalemia \>6.5 mmol/L
  • severe acidosis with pH\<7.15

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

Related Publications (2)

  • 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

  • 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.

    PMID: 25855898DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Officials

  • Danilo Fliser, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2007

First Posted

September 14, 2007

Study Start

July 1, 2003

Study Completion

May 1, 2006

Last Updated

September 17, 2007

Record last verified: 2007-09

Locations

DE(1)