NCT00924222

Brief Summary

Organ protection, volatile anesthetics, postconditioning. Sedation of patients on ICU after cardiac surgery with cardiopulmonary bypass with either propofol or sevoflurane. Evaluation of organ function and inflammatory mediators in the blood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration 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

October 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 12, 2011

Status Verified

October 1, 2011

Enrollment Period

2.1 years

First QC Date

June 17, 2009

Last Update Submit

October 11, 2011

Conditions

Cardiac On-pump Surgery

Outcome Measures

Primary Outcomes (1)

  • Myocardial injury markers (myoglobin, creatine kinase, myocard specific creatine kinase, and troponin T)

    Start and end of ICU stay

Secondary Outcomes (1)

  • Oxygenation index, postoperative pulmonary complications, ICU stay (days), length of hospitalisation

    Start with surgery until end of hospitalisation

Study Arms (2)

Sevoflurane

EXPERIMENTAL
Drug: SevofluraneDrug: Propofol

Propofol

EXPERIMENTAL
Drug: SevofluraneDrug: Propofol

Interventions

SevofluraneDRUG

Sedation with sevoflurane

PropofolSevoflurane
PropofolDRUG

Sedation on intensive care unit with propofol

PropofolSevoflurane

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CABG and/or heart valve surgery with CPB
  • Ejection fraction (EF) = 30%
  • Canadian Cardiovascular Society (CCS) classification = 3
  • Ages 18 to 90 years old

You may not qualify if:

  • Pulmonary disease: forced expiratory volume in one second (FEV1) \< 80%; FEV1/forced vital capacity (FVC) \< 70%
  • Renal disease and/ or creatinine-clearance \< 60 ml/min
  • Previous cardiac surgery
  • Emergency procedures
  • Postoperative intra aortic balloon pump (IABP) requirement
  • Myocardial infarction \< 7d
  • Steroid treatment
  • Insulin-dependent diabetes
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Zurich, Switzerland

Location

Related Publications (1)

  • Steurer MP, Steurer MA, Baulig W, Piegeler T, Schlapfer M, Spahn DR, Falk V, Dreessen P, Theusinger OM, Schmid ER, Schwartz D, Neff TA, Beck-Schimmer B. Late pharmacologic conditioning with volatile anesthetics after cardiac surgery. Crit Care. 2012 Oct 14;16(5):R191. doi: 10.1186/cc11676.

    PMID: 23062276DERIVED

MeSH Terms

Interventions

SevofluranePropofol

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 17, 2009

First Posted

June 18, 2009

Study Start

October 1, 2007

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

October 12, 2011

Record last verified: 2011-10

Locations

CH(1)