NCT00971971

Brief Summary

Intradialytic hypotension (IH) is a major complication during acute hemodialysis. The aim of this study was to evaluate the effects of dialysate temperature (DT) reduction with Na and ultrafiltration (UF) profiling on hemodynamics of critically ill acute kidney injury (AKI) patients submitted to sustained low-efficiency dialysis (SLED).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2009

Completed
Last Updated

September 7, 2009

Status Verified

September 1, 2009

Enrollment Period

1.7 years

First QC Date

September 3, 2009

Last Update Submit

September 4, 2009

Conditions

Acute Kidney InjuryAcute Renal Failure

Keywords

HypotensionAcute renal failureacute kidney injurydialysisICU

Outcome Measures

Primary Outcomes (1)

  • Intradialytic hypotension

    At dialysis session

Secondary Outcomes (1)

  • Dialysis dose

    dialysis session

Study Arms (2)

Control

NO INTERVENTION

Traditional SLED

Procedure: Standard SLED

Profiling

EXPERIMENTAL

dialysate temperature reduction with Na and ultrafiltration (UF) profiling

Procedure: Dialysis

Interventions

DialysisPROCEDURE

dialysate temperature (DT) reduction with Na and ultrafiltration (UF) profiling

Profiling
Standard SLEDPROCEDURE
Control

Eligibility Criteria

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

You may qualify if:

  • Acute renal failure with a need of dialysis.

You may not qualify if:

  • Patients with basal serum creatinine \> 3 mgdL.
  • Patients submitted to renal transplantation.
  • Patients unlikely to survive.
  • Declination in authorization to participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

São Jose do Rio Preto Medical School

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

MeSH Terms

Conditions

Acute Kidney InjuryHypotension

Interventions

Dialysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chemistry Techniques, AnalyticalInvestigative TechniquesChemical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 3, 2009

First Posted

September 4, 2009

Study Start

October 1, 2005

Primary Completion

July 1, 2007

Study Completion

September 1, 2009

Last Updated

September 7, 2009

Record last verified: 2009-09

Locations

BR(1)