Trial Outcomes & Findings for Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock (NCT NCT00604019)

NCT ID: NCT00604019

Last Updated: 2023-01-11

Results Overview

We measured 28 day all-cause mortality in randomized patients with septic shock managed with a vasopressor protocol containing either dopamine versus norepinephrine.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 252 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2023-01-11

Participant Flow

Dates of enrollment were from July 2005 thru July 2008 at RUSH University Medical Center in the Medical Intensive Care Unit

Participant milestones

Measure	Dopamine Dopaime infusion via central catheter	Norepinephrine Norepinephrine infusion via central catheter
Overall Study STARTED	134	118
Overall Study COMPLETED	134	118
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock

Baseline characteristics by cohort

Measure	Dopamine n=134 Participants Patients that get DA infusion	Norepinephrine n=118 Participants Patients that get NE infusion	Total n=252 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants
Age, Categorical >=65 years	34 Participants n=5 Participants	18 Participants n=7 Participants	52 Participants n=5 Participants
Age, Continuous	56 years STANDARD_DEVIATION 18 • n=5 Participants	60 years STANDARD_DEVIATION 15 • n=7 Participants	57 years STANDARD_DEVIATION 20 • n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	52 Participants n=7 Participants	122 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	66 Participants n=7 Participants	130 Participants n=5 Participants
Region of Enrollment United States	134 participants n=5 Participants	118 participants n=7 Participants	252 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

We measured 28 day all-cause mortality in randomized patients with septic shock managed with a vasopressor protocol containing either dopamine versus norepinephrine.

Outcome measures

Measure	Dopamine n=134 Participants Patients getting DA infusion	Norepinephrine n=118 Participants Patients getting NE infusion
Efficacy and Safety of Dopamine Versus Norepinephrine in Septic Shock	67 participants	51 participants

SECONDARY outcome

Timeframe: 28 days

Population: cardiac rhythm monitoring

We evaluated adverse events including arrhythmias in the two vasopressor protocol study groups

Outcome measures

Measure	Dopamine n=134 Participants Patients getting DA infusion	Norepinephrine n=118 Participants Patients getting NE infusion
Safety, Arrythmia - Yes or no for Each Group No arrhythmia detected	83 Participants	104 Participants
Safety, Arrythmia - Yes or no for Each Group arrhythmia detected	51 Participants	14 Participants

Adverse Events

Dopamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Norepinephrine

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

Gourang Patel, PharmD

RUSH University Medical Center

Phone: 312-942-4258

Email: gourang_p_patel@rush.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place