Trial Outcomes & Findings for Variable Rate Phenylephrine Infusion for Prevention of Spinal-induced Hypotension for Cesarean Delivery (NCT NCT01378325)

Results Overview

Physician interventions are triggered by hemodynamic changes more than 20% of baseline. The intervention can be one or more of the following: * stopping the phenylephrine infusion * changing the rate of phenylephrine infusion * rescue intravenous bolus of phenylephrine (100 µg) for hypotension * rescue intravenous bolus of atropine (0.4 mg) for bradycardia

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

Patients will be followed up throughout the Cesarean delivery (average of 1.5 hours).

Results posted on

2014-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	Phenylephrine PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery Phenylephrine: Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline	Saline crystalloid coload with lactated Ringer solution combined with prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
Overall Study STARTED	40	40
Overall Study COMPLETED	40	39
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Phenylephrine PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery Phenylephrine: Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline	Saline crystalloid coload with lactated Ringer solution combined with prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
Overall Study Protocol Violation	0	1

Baseline Characteristics

Variable Rate Phenylephrine Infusion for Prevention of Spinal-induced Hypotension for Cesarean Delivery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Saline n=39 Participants Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline	Phenylephrine n=40 Participants PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery	Total n=79 Participants Total of all reporting groups
Age, Continuous	33.5 years STANDARD_DEVIATION 5 • n=5 Participants	32.5 years STANDARD_DEVIATION 5 • n=7 Participants	33 years STANDARD_DEVIATION 5 • n=5 Participants
Sex/Gender, Customized Number of Female Participants	39 participants n=5 Participants	40 participants n=7 Participants	79 participants n=5 Participants

PRIMARY outcome

Timeframe: Patients will be followed up throughout the Cesarean delivery (average of 1.5 hours).

Physician interventions are triggered by hemodynamic changes more than 20% of baseline. The intervention can be one or more of the following: * stopping the phenylephrine infusion * changing the rate of phenylephrine infusion * rescue intravenous bolus of phenylephrine (100 µg) for hypotension * rescue intravenous bolus of atropine (0.4 mg) for bradycardia

Outcome measures

Outcome measures
Measure	Phenylephrine n=40 Participants PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery Phenylephrine: Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline	Saline n=39 Participants crystalloid coload with lactated Ringer solution combined with prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
Number of Physician Interventions Needed to Maintain Maternal Blood Pressure After Spinal Anesthesia Within 20% of Baseline and to Treat Bradycardia During Cesarean Delivery.	0 number of interventions Interval 0.0 to 6.0	3 number of interventions Interval 0.0 to 9.0

Adverse Events

Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phenylephrine

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

Sahar Siddik-Sayyid

AUBMC

Phone: 9611350000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place