NCT01376531

Brief Summary

The aim of the study is to characterize the influence of continuous veno-venous hemodialysis on the cerebrovascular autoregulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

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

January 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
Last Updated

April 15, 2013

Status Verified

April 1, 2013

Enrollment Period

5 months

First QC Date

June 15, 2011

Last Update Submit

April 12, 2013

Conditions

Keywords

acute renal failurecerebrovascular autoregulationtranscranial Dopplercontinuous veno-venous hemodialysis

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline cerebrovascular autoregulation to cerebrovascular autoregulation during continuous veno-venous hemodialysis

    Is there an influence of continuous veno-venous hemodialysis at the cerebrovascular autoregulation, which would be a side effect with limiting use in patients with brain injury or the need of intensive monitoring of cerebral perfusion pressure in this patients.

    1 Year

Study Arms (1)

acute renal failure

patients at intensive care unit with definition of acute renal failure and the need for continuous veno-venous hemodialysis

Procedure: continuous veno-venous hemodialysis

Interventions

continuous veno-venous hemodialysis

Also known as: CVVHD
acute renal failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients at ICU with acute renal failure and the need of continuos veno-venous hemodialysis

You may qualify if:

  • acute renal failure
  • need for continuous veno-venous hemodialysis
  • age \>18 Years

You may not qualify if:

  • Sepsis
  • Preexisting cerebral illness
  • traumatic brain injury
  • Meningitis or encephalitis
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University medical centre

Mainz, 55131, Germany

Location

Related Publications (1)

  • Schramm P, Closhen D, Wojciechowski J, Berres M, Klein KU, Bodenstein M, Werner C, Engelhard K. Cerebrovascular autoregulation in critically ill patients during continuous hemodialysis. Can J Anaesth. 2013 Jun;60(6):564-9. doi: 10.1007/s12630-013-9912-z. Epub 2013 Mar 28.

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Patrick Schramm, MD

    Department of Anesthesiology, University medicine Mainz, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physician

Study Record Dates

First Submitted

June 15, 2011

First Posted

June 20, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

April 15, 2013

Record last verified: 2013-04

Locations