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

An observational study of Septic Shock, run by Rush University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Retrospective study to examine the effects of chronic antihypertensive medications on vasopressor dosing in septic shock Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Septic Shock
How many people: 133 participants
Where: 1 siteUnited States
Study dates: Aug 2016to 31 Mar 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult, non-pregnant medical intensive care unite (MICU) patients with septic shock requiring vasopressor support

Who may be able to join

Adult patients 18 years of age or older
Diagnosis of septic shock requiring vasopressor therapy (norepinephrine, epinephrine, phenylephrine, dopamine, or vasopressin)
Admitted to an intensive care unit (ICU) at Rush University Medical Center (RUMC)
Time frame: 01/01/2012 to 07/1/2016

Who cannot join

Pregnant patients
Transfer from outside hospital on vasopressors
Admitted in cardiopulmonary arrest
Prior arrest within 24 hours of admission to RUMC

Trial locations and contacts

1 site in 1 country.

United States1 site

Rush Univeristy Medical Center
Chicago, Illinois, 60612

Other trials in United States

About this study

Retrospective study to examine the effects of chronic antihypertensive medications on vasopressor dosing in septic shock

Read the detailed description

This will be a retrospective four-cohort study. The four cohorts will be septic shock patients that were: 1) not on either a chronic β-blocker or chronic angiotensin-converting-enzyme inhibitor (ACE-Inhibitor), 2) on chronic β-blocker, 3) on ACE-Inhibitor, and 4) on both chronic β-blocker and ACE-inhibitor

Conditions: Septic Shock
Keywords: Chronic antihypertensives, Septic shock, Vasopressor, Vasopressor dosing
Medical subject headings: Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02884011
Study group	Role	What they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Vasopressor Dose
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
Measured: 48 hours

Secondary outcomes (7)

30 mL/kg Fluid Within 6h
Number of Participants with 30 mL/kg Fluid Within 6 Hours
Measured: 48 hours
Inotrope Use
Cumulative inotrope use at different time points (total mg). Example inotropes include dobutamine and milrinone
Measured: 6, 12, 24, 48 hours
Hydrocortisone Use
Cumulative hydrocortisone (mg) use at different time points
Measured: 6, 12, 24, 48 hours
Cumulative Vasopressor Dose for Patients Receiving Other Antihypertensives
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
Measured: 6, 12, 24, 48 hours
6-hour Vasopressor Dose
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
Measured: 6 hours
12-hour Vasopressor Dose
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
Measured: 12 hours
24-hour Vasopressor Dose
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
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201631 Mar 2017

First posted30 Aug 2016 (estimated)
Study startAug 2016
Primary completionFeb 2017
Study completion31 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Septic ShockStudies of the same condition, open and under way.
More trials run by Rush University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02884011
Sponsor's protocol ID: 16081001
Status last verified: Nov 2024
First submitted: 12 Aug 2016
Last updated: 3 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided: To be determined

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis

All Septic Shock trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Effect of Chronic Antihypertensive Therapy on Vasopressor Dosing in Septic Shock
ClinicalTrials.gov ID: NCT02884011
Acronym / sponsor ID: 16081001
Conditions: Septic Shock
Keywords: Chronic antihypertensives, Septic shock, Vasopressor, Vasopressor dosing
Study type: Observational
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Rush University Medical CenterUniversity, hospital or other
Study start: Aug 2016
Primary completion: Feb 2017 (actual)
Study completion: 31 Mar 2017 (actual)
First posted: 30 Aug 2016 (estimated)
Results: Posted 3 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Retrospective study to examine the effects of chronic antihypertensive medications on vasopressor dosing in septic shock

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 4

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult, non-pregnant medical intensive care unite (MICU) patients with septic shock requiring vasopressor support

Key inclusion criteria (4 listed)

Adult patients 18 years of age or older
Diagnosis of septic shock requiring vasopressor therapy (norepinephrine, epinephrine, phenylephrine, dopamine, or vasopressin)
Admitted to an intensive care unit (ICU) at Rush University Medical Center (RUMC)
Time frame: 01/01/2012 to 07/1/2016

Key exclusion criteria (4 listed)

Pregnant patients
Transfer from outside hospital on vasopressors
Admitted in cardiopulmonary arrest
Prior arrest within 24 hours of admission to RUMC

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Total Vasopressor Dose
Time frame: 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

7 secondary outcomes

30 mL/kg Fluid Within 6h
Time frame: 48 hours
Inotrope Use
Time frame: 6, 12, 24, 48 hours
Hydrocortisone Use
Time frame: 6, 12, 24, 48 hours
Cumulative Vasopressor Dose for Patients Receiving Other Antihypertensives
Time frame: 6, 12, 24, 48 hours
6-hour Vasopressor Dose
Time frame: 6 hours
12-hour Vasopressor Dose
Time frame: 12 hours
24-hour Vasopressor Dose
Time frame: 24 hours

Results and safety

Results posted to the registry on 3 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No Chronic Antihypertensives	51	51
β-blocker	46	46
ACE-Inhibitor	17	17
Both β-blocker and ACE-inhibitor	19	19

Primary outcome: Total Vasopressor Dose

Time frame: 48 hours. Median (Inter-Quartile Range). Unit: mg

Measure	No Beta-blocker or ACE Inhibitor n = 51	Beta-blocker Only n = 46	Ace Inhibitor n = 17	Beta-blocker and ACE Inhibitor n = 19
Value	13.7 (6.0 to 35.7)	13.1 (5.4 to 23.9)	13.2 (1.2 to 36.7)	11.3 (4.7 to 42.9)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the inpatient hospital stay, up to 48 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Chronic Antihypertensives	0 of 51 (0%)	0 of 51 (0%)	21 of 51
β-blocker	0 of 46 (0%)	0 of 46 (0%)	26 of 46
ACE-Inhibitor	0 of 17 (0%)	0 of 17 (0%)	6 of 17
Both β-blocker and ACE-inhibitor	0 of 19 (0%)	0 of 19 (0%)	11 of 19

Limitations and caveats (from the sponsor): Adherence to prescribed chronic β-blockers or ACE inhibitors could not be confirmed. The electronic medical record charting by the staff may be subject to inaccuracies in vasopressor dose infusion changes and documentation. Small sample size.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. To be determined

Related trials for Septic Shock

Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joshua DeMott, Pharm.D. principal investigator

Rush University Medical Center

Ishaq Lat, Pharm.D. principal investigator

Rush University Medical Center

Gourang Patel, Pharm.D. principal investigator

Rush University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Septic Shock, run by Rush University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Vasopressor Dose (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02884011.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.