NCT00535808

Brief Summary

In a prospective and randomized study protocol, three different blood pressure regulating agents (nitroprusside, nitroglycerine, sevoflurane) will be compared concerning their effect on the cerebral oxygen balance between both hemispheres during aortic coarctation repair. Cerebral and somatic saturation will be monitored non-invasively and continuously via optical sensors applied to the right and left forehead and the somatic regions. Arterial blood pressure, central venous pressure, heart rate and systemic saturation will be recorded continuously. Intermittently, arterial and venous blood gas analysis will be performed at 6 definite time intervals. The study ends at the end of the operation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2007

Typical duration for phase_2

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

First Submitted

Initial submission to the registry

September 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

July 13, 2012

Status Verified

July 1, 2012

Enrollment Period

3.4 years

First QC Date

September 25, 2007

Last Update Submit

July 12, 2012

Conditions

Cerebral Oxygenation

Outcome Measures

Primary Outcomes (1)

  • Cerebral saturation

    During operation

Study Arms (3)

1

EXPERIMENTAL

Administration of nitroprusside

Drug: nitroprusside

2

EXPERIMENTAL

Administration of nitroglycerine

Drug: nitroglycerine

3

EXPERIMENTAL

Administration of sevoflurane

Drug: sevoflurane

Interventions

nitroprussideDRUG

Administration of nitroprusside

1
nitroglycerineDRUG

Administration of nitroglycerine

2
sevofluraneDRUG

Administration of Sevoflurane

3

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All neonates and infants
  • Aged 0-18 year
  • With aortic coarctation requiring surgical correction without the additional use of cardiopulmonary bypass will be included.

You may not qualify if:

  • All patients with an associated cardiac effect are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Interventions

NitroprussideNitroglycerinSevoflurane

Intervention Hierarchy (Ancestors)

FerricyanidesCyanidesAnionsIonsElectrolytesInorganic ChemicalsFerric CompoundsIron CompoundsHydrogen CyanideNitrogen CompoundsNitro CompoundsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Annelies Moerman, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2007

First Posted

September 26, 2007

Study Start

October 1, 2007

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

July 13, 2012

Record last verified: 2012-07

Locations

BE(1)