Trial Outcomes & Findings for Up-Down Determination of the ED90 of Phenylephrine for Hypotension Prophylaxis in Cesarean Delivery (NCT NCT00796328)

Results Overview

The effective dose at which 90% of subjects will have a "positive" response to a phenylephrine infusion, i.e. no spinal induced hypotension. We hypothesize that the ED90 will be between 40 - 60 mcg/min.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

45 participants

Primary outcome timeframe

Spinal administration until delivery

Results posted on

2018-04-23

Participant Flow

Six subjects were withdrawn from the study

Participant milestones

Participant milestones
Measure	Phenylephrine Infusion Phenylephrine infusion : Up-down, biased coin design
Overall Study STARTED	46
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Phenylephrine Infusion Phenylephrine infusion : Up-down, biased coin design
Overall Study experienced hypotension requiring tx	6

Baseline Characteristics

Up-Down Determination of the ED90 of Phenylephrine for Hypotension Prophylaxis in Cesarean Delivery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phenylephrine Infusion n=46 Participants Phenylephrine infusion : Up-down, biased coin design
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	46 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: Spinal administration until delivery

The effective dose at which 90% of subjects will have a "positive" response to a phenylephrine infusion, i.e. no spinal induced hypotension. We hypothesize that the ED90 will be between 40 - 60 mcg/min.

Outcome measures

Outcome measures
Measure	Phenylephrine Infusion n=40 Participants Phenylephrine infusion : Up-down, biased coin design
Effective Dose of Phenylephrine at Which 90% of Subjects Have no Spinal Induced Hypotension	NA dose of phenylephrine An error in the up-down sequencing was discovered. The subsequent participants would have allocated to a dose incorrectly as per the biased coin design. The results are invalid.

Adverse Events

Phenylephrine Infusion

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

Dr. Ron George

IWK Health Centre

Phone: 470-6627

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place