NCT00752453

Brief Summary

Study of the kinetics of uremic toxins in the ICU patients with acute renal failure, in order to optimize the dialysis dose: patients with lactate acidosis. The sampling of blood and dialysate will be done during dialysis with different durations (4, 6 and 8 h)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 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

July 31, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2008

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2013

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

5.2 years

First QC Date

September 12, 2008

Last Update Submit

December 14, 2022

Conditions

Acute Renal Failure

Keywords

ICUpatientslactateacidosis

Outcome Measures

Primary Outcomes (1)

  • Toxin removal

    During dialysis

Study Arms (3)

1

EXPERIMENTAL

Dialysis during 4 hours

Procedure: Dialysis during 4 hours

2

EXPERIMENTAL

Dialysis during 6 hours

Procedure: Dialysis during 6 hours

3

EXPERIMENTAL

Dialysis during 8 hours

Procedure: Dialysis during 8 hours

Interventions

Dialysis during 4 hoursPROCEDURE

Blood and dialysate sampling

1
Dialysis during 6 hoursPROCEDURE

Blood and dialysate sampling

2
Dialysis during 8 hoursPROCEDURE

Blood and dialysate sampling

3

Eligibility Criteria

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

You may qualify if:

  • Includes ICU patients with lactate acidosis with acute renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Acute Kidney InjuryAcidosis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Raymond Vanholder, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2008

First Posted

September 15, 2008

Study Start

July 31, 2008

Primary Completion

October 4, 2013

Study Completion

December 31, 2013

Last Updated

December 15, 2022

Record last verified: 2022-12

Locations

BE(1)