Trial Outcomes & Findings for Pharmacokinetic Alterations During ECMO (NCT NCT01938079)

Results Overview

Culmulative fentanyl equivalents meaning the combination of sedative drug regimen - measured in mg - from ECMO initiation to decision to achieve wakefulness.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Up to 14 days

Results posted on

2016-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	Sedative Without Ketamine Subjects will receive sedative drug regimen without Ketamine. Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation.	Sedative With Ketamine Subjects will receive sedative drug regimen with Ketamine. Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO. Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetic Alterations During ECMO

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sedative Without Ketamine n=10 Participants Subjects will receive sedative drug regimen without Ketamine. Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation.	Sedative With Ketamine n=10 Participants Subjects will receive sedative drug regimen with Ketamine. Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO. Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation.	Total n=20 Participants Total of all reporting groups
Age, Continuous	44 years n=5 Participants	43 years n=7 Participants	44 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 14 days

Culmulative fentanyl equivalents meaning the combination of sedative drug regimen - measured in mg - from ECMO initiation to decision to achieve wakefulness.

Outcome measures

Outcome measures
Measure	Sedative Without Ketamine n=10 Participants Subjects will receive sedative drug regimen without Ketamine. Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation.	Sedative With Ketamine n=10 Participants Subjects will receive sedative drug regimen with Ketamine. Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO. Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation.
Cumulative Fentanyl Equivalents From ECMO Initiation to Decision to Achieve Wakefulness	330 mg Interval 101.0 to 1971.0	834 mg Interval 379.0 to 2329.0

Adverse Events

Sedative Without Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sedative With Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amy L. Dzierba, Pharm.D., BCPS, BCCCP, FCCM

Columbia University

Phone: 212-305-5852

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place