NCT02529514

Brief Summary

Baclo-Sleep trial aims to investigate the effect of baclofen on sleep after scheduled cardiac surgery.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
suspended

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

June 4, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

11 months

First QC Date

June 4, 2015

Last Update Submit

May 11, 2016

Conditions

Sleep

Keywords

BaclofenCardiac SurgeryPolysomnographyIntensive Care UnitsSleep

Outcome Measures

Primary Outcomes (1)

  • Polysomnography (quantity & quality of sleep)

    Sleep assessment by polysomnography

    Participants will be followed for the duration of hospital stay, an expected average of 10 days

Study Arms (2)

Baclofen

ACTIVE COMPARATOR

Baclofen 25 mg per os for 7 days at 10 pm every day

Drug: Baclofen

Placebo

PLACEBO COMPARATOR

Placebo per os for 7 days at 10 pm every day

Drug: Placebo

Interventions

BaclofenDRUG

25 mg for 7 days at 10 pm every day

Baclofen
PlaceboDRUG

Placebo for 7 days at 10 pm every day

Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective cardiac surgery

You may not qualify if:

  • Haemodynamic instability
  • Epilepsy
  • Psychotic disturbances
  • Acute / Chronic respiratory failure
  • Morbid obesity (BMI \> 45 kg/m2)
  • Sleep apnea (treated)
  • Severe hepatic or renal failure
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Liège

Liège, Liège, 4000, Belgium

Location

MeSH Terms

Interventions

Baclofen

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Pierre Damas, Professor

    Soins intensifs généraux

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 4, 2015

First Posted

August 20, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations

BE(1)