NCT02378168

Brief Summary

Retrospective analysis of a 6-month follow up within a randomised controlled study in cardiac surgery with pharmacological postconditioning (sedation on intensive care unit with sevoflurane)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

February 27, 2015

Last Update Submit

November 2, 2016

Conditions

Heart Surgical Procedures

Keywords

postconditioningsix month follow upcardiac eventnon-cardiac event

Outcome Measures

Primary Outcomes (1)

  • the proportion of patients with cardiac events

    dysrhythmias, congestive heart failure and cardiac ischemic event

    6 months after cardiac surgery

Secondary Outcomes (1)

  • proportion of patients experiencing non-cardiac events

    6 months after cardiac surgery

Study Arms (1)

cohort of RCT (StV 5-2007; NCT00924222)

Patient group with either sevoflurane or propofol sedation of the RCT (StV 5-2007; NCT00924222)

Other: no intervention; retrospective study

Interventions

no intervention; retrospective studyOTHER
cohort of RCT (StV 5-2007; NCT00924222)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who had successfully completed the late postconditioning trial (NCT00924222) were included in this retrospective follow-up analysis.

All patients who had successfully completed the late post-conditioning trial were included in this retrospective follow-up analysis. Written and informed consent of all patients included in the first study had to be available.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

University Hospital of Zurich

Zurich, Switzerland

Location

University Hospital Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Retrospective Studies

Intervention Hierarchy (Ancestors)

Case-Control StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesCohort StudiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Beatrice Beck Schimmer, Prof

    University Hospital Zurich, Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2015

First Posted

March 4, 2015

Study Start

April 1, 2014

Primary Completion

October 1, 2014

Study Completion

November 1, 2014

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

CH(2)