Trial Outcomes & Findings for Evaluating the Effect of Chronic Antihypertensive Therapy on Vasopressor Dosing in Septic Shock (NCT NCT02884011)

Results Overview

The primary objective is to determine the effect of chronic β-blocker or ACE-inhibitor on vasopressor dosing in the first 48 hours of septic shock. Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine

Recruitment status

COMPLETED

Target enrollment

133 participants

Primary outcome timeframe

48 hours

Results posted on

2025-01-03

Participant Flow

retrospective study

Participant milestones

Participant milestones
Measure	No Chronic Antihypertensives not on either a chronic β-blocker or ACE-Inhibitor	β-blocker on chronic β-blocker	ACE-Inhibitor on chronic ACE-Inhibitor	Both β-blocker and ACE-inhibitor on both chronic β-blocker and ACE-inhibitor
Overall Study STARTED	51	46	17	19
Overall Study COMPLETED	51	46	17	19
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating the Effect of Chronic Antihypertensive Therapy on Vasopressor Dosing in Septic Shock

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Chronic Antihypertensives n=51 Participants not on either a chronic β-blocker or ACE-Inhibitor	β-blocker n=46 Participants on chronic β-blocker	ACE-Inhibitor n=17 Participants on chronic ACE-Inhibitor	Both β-blocker and ACE-inhibitor n=19 Participants on both chronic β-blocker and ACE-inhibitor	Total n=133 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	67 years n=7 Participants	70 years n=5 Participants	66 years n=4 Participants	65 years n=21 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	22 Participants n=7 Participants	7 Participants n=5 Participants	11 Participants n=4 Participants	59 Participants n=21 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	24 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	74 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	27 Participants n=7 Participants	6 Participants n=5 Participants	9 Participants n=4 Participants	60 Participants n=21 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	15 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	53 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	20 Participants n=21 Participants

PRIMARY outcome

Timeframe: 48 hours

The primary objective is to determine the effect of chronic β-blocker or ACE-inhibitor on vasopressor dosing in the first 48 hours of septic shock. Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine

Outcome measures

Outcome measures
Measure	No Beta-blocker or ACE Inhibitor n=51 Participants No beta-blocker or ACE inhibitor	Beta-blocker Only n=46 Participants Beta-blocker only	Ace Inhibitor n=17 Participants Ace inhibitor	Beta-blocker and ACE Inhibitor n=19 Participants Beta-blocker and ACE inhibitor
Total Vasopressor Dose	13.7 mg Interval 6.0 to 35.7	13.1 mg Interval 5.4 to 23.9	13.2 mg Interval 1.2 to 36.7	11.3 mg Interval 4.7 to 42.9

SECONDARY outcome

Timeframe: 48 hours

Number of Participants with 30 mL/kg Fluid Within 6 Hours

Outcome measures

Outcome measures
Measure	No Beta-blocker or ACE Inhibitor n=51 Participants No beta-blocker or ACE inhibitor	Beta-blocker Only n=46 Participants Beta-blocker only	Ace Inhibitor n=17 Participants Ace inhibitor	Beta-blocker and ACE Inhibitor n=19 Participants Beta-blocker and ACE inhibitor
30 mL/kg Fluid Within 6h	36 Participants	27 Participants	12 Participants	16 Participants

SECONDARY outcome

Timeframe: 6, 12, 24, 48 hours

Cumulative inotrope use at different time points (total mg). Example inotropes include dobutamine and milrinone

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6, 12, 24, 48 hours

Cumulative hydrocortisone (mg) use at different time points

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6, 12, 24, 48 hours

To determine cumulative vasopressor dose at various time points of patients on chronic calcium channel blocker or other antihypertensives (i.e., hydralazine, clonidine, angiotensin-receptor-blocker (ARB), etc). Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 hours

Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 hours

Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine

Outcome measures

Outcome data not reported

Adverse Events

No Chronic Antihypertensives

Serious events: 0 serious events

Other events: 0 other events

Deaths: 21 deaths

β-blocker

Serious events: 0 serious events

Other events: 0 other events

Deaths: 26 deaths

ACE-Inhibitor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

Both β-blocker and ACE-inhibitor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 11 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joshua DeMott

Rush University Medical Center

Phone: 312-947-0226

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place