NCT01602640

Brief Summary

Hypothesis: Morphine infusion decreases time to mechanical ventilation weaning and extubation, as compared to the combination of fentanyl and midazolam in critically-ill patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

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

January 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2012

Completed
Last Updated

May 21, 2012

Status Verified

May 1, 2012

Enrollment Period

3.1 years

First QC Date

April 18, 2012

Last Update Submit

May 17, 2012

Conditions

Respiratory Failure

Keywords

sedationcritical caremorphinefentanylanalgesic based sedation

Outcome Measures

Primary Outcomes (1)

  • Time from sedation discontinuation to first T-Tube time from sedation

    12-120 hours

Secondary Outcomes (1)

  • Time from sedation discontinuation to extubation time from sedation

    12-180 hours

Study Arms (2)

Morphine

EXPERIMENTAL
Drug: Morphine infusion

Fentanyl and Midazolam

ACTIVE COMPARATOR

Control

Drug: Fentanyl and Midazolam infusion

Interventions

Morphine infusionDRUG

Conventional dose

Morphine
Fentanyl and Midazolam infusionDRUG

Conventional dose

Fentanyl and Midazolam

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults admitted to ICU requiring mechanical ventilation Informed consent

You may not qualify if:

  • Less than 18 years old
  • Consent denial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica de los Andes IPS

Tunja, Departamento de Boyacá, 8, Colombia

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Efrain Riveros, Principal investigator

    Clinica de los Andes IPS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 18, 2012

First Posted

May 21, 2012

Study Start

January 1, 2009

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

May 21, 2012

Record last verified: 2012-05

Locations

CO(1)