Septic ShockPhase 4NCT06122987
Hemodynamic Response to Angiotensin-II When Used as the Second Vasopressor Agent for Septic Shock
A Phase 4 study testing Angiotensin II and hydrocortisone sodium succinate in people with Septic Shock and Shock, run by Kingman Regional Medical Center at 1 site in United States.
Trial summary
Norepinephrine is a catecholamine that is the first-line vasopressor for septic shock. The addition of non-catecholamine vasopressors, including vasopressin and angiotensin-II may be used in adults with septic shock that have inadequate mean arterial pressure while on norepinephrine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Shock, Sepsis
- What is being tested?
- Angiotensin II and hydrocortisone sodium succinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2023to Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients admitted to the ICU within 12 hours of presentation to the emergency department for septic shock requiring 15-25 mcg/min of norepinephrine. Septic shock will be defined as having a known or presumed infection with two or more criteria of systemic inflammatory response syndrome, a mean arterial pressure <65 mm Hg despite fluid resuscitation requiring vasopressor support, and a serum lactate >2 mmol/L. Criteria of systemic inflammatory response syndrome include a temperature >100.4°F or <96.8°F; heart rate >90/min; respiratory rate >20/min and a white blood cell count >12,000/mm3 or <4,000/mm3.
Who cannot join
- Age <18 years
- Pregnancy or lactation
- Known allergic reactions to angiotensin-II or hydrocortisone sodium succinate
- Requiring >25 mcg/min of norepinephrine or on any vasopressor other than norepinephrine at study enrollment
- Clinically significant bleeding precluding the use of chemical prophylaxis for venous thromboembolism
- Treatment with another investigational drug or other intervention during study timeframe
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kingman Regional Medical Center
Kingman, Arizona, 86401
Tyson Dietrich, PharmD, 928-263-3933, tdietrich@azkrmc.org
About this study
Official title: An Open-label, Single-arm, Single-center Study Evaluating the Hemodynamic Response to Angiotensin-II When Used as the Second Vasopressor Agent for Septic Shock
Norepinephrine is a catecholamine that is the first-line vasopressor for septic shock. The addition of non-catecholamine vasopressors, including vasopressin and angiotensin-II may be used in adults with septic shock that have inadequate mean arterial pressure while on norepinephrine. Uncertainty exists regarding the timing of initiation of these agents and there is a lack of data comparing their safety and efficacy.
The current literature suggests that earlier initiation of angiotensin-II will have a more significant reduction on norepinephrine-equivalent dose compared to later initiation. In addition, approximately half of patients initiated on vasopressin do not have an early hemodynamic response 6 hours after initiation. The purpose of this study is to evaluate the efficacy of angiotensin-II when used as the second vasopressor agent for septic shock.
Read the detailed description
Objectives:
Primary Objective:
- To evaluate the efficacy of ang-II when used as the second vasopressor agent for septic shock
Secondary Objectives:
- To assess the duration of response to ang-II
- To assess overall survival
- To assess the amount of time spent in the ICU
- To assess the need for renal replacement therapy
- To assess the overall duration of vasoactive medication use
- To assess toxicity and tolerability
- Conditions
- Septic Shock, Shock, Sepsis, Systemic Inflammatory Response Syndrome
- Being tested
- Angiotensin II and hydrocortisone sodium succinate
- Keywords
- Sepsis, Angiotensin II, Hydrocortisone
- Medical subject headings
- Shock, Septic, Shock, Sepsis, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin II and hydrocortisone sodium succinateDrug
Also called Giapreza
Intravenous infusion angiotensin II (titrated for each individual patient by effect) and hydrocortisone 50 mg intravenous bolus every 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Drug: Angiotensin II Other Names: Giapreza Receives: Drug: Angiotensin II and hydrocortisone sodium succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hemodynamic response, defined as a decrease in norepinephrine-equivalent dose with a MAP ≥65 mm Hg at 1 hour after initiation of angiotensin-II
Defined as a decrease in norepinephrine-equivalent dose with a MAP ≥65 mm Hg at 1 hour after initiation of angiotensin-II.
Measured: 1 hour
Secondary outcomes (7)
The incidence of hemodynamic response at 3 hours after initiation of angiotensin-II
Defined as a decrease in norepinephrine-equivalent dose with a MAP ≥65 mm Hg at 3 hours after initiation of angiotensin-II.
Measured: 3 hours
The incidence of hemodynamic response at 6 hours after initiation of angiotensin-II
Defined as a decrease in norepinephrine-equivalent dose with a MAP ≥65 mm Hg at 6 hours after initiation of angiotensin-II.
Measured: 6 hours
28-day mortality
Defined as all cause mortality up to 28 days from study enrollment.
Measured: 28 days
ICU length of stay
Defined as the time spent within the ICU until discharge to a step down unit.
Measured: 1 year
Need for renal replacement therapy
Defined as patients started on either continuous renal replacement therapy (CRRT) or intermittent hemodialysis (IHD) during the study period.
Measured: 1 year
Vasoactive medication duration overall
Defined as the duration (hours) of vasoactive medication use during the study period.
Measured: 1 year
Incidence of adverse reactions
Define as an unexpected or unintended effect suspected to be caused by a medicine.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start4 Dec 2023
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kingman Regional Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- La Jolla Pharmaceutical Company
- Responsible party
- Principal investigator, Tyson Dietrich, Kingman Regional Medical Center
- Investigators
- Tyson Dietrich, PharmD, Principal investigator, Kingman Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122987
- Sponsor's protocol ID
- KRMC 0284
- Status last verified
- May 2024
- First submitted
- 3 Nov 2023
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Single-center Study Evaluating the Hemodynamic Response to Angiotensin-II When Used as the Second Vasopressor Agent for Septic Shock
- ClinicalTrials.gov ID
- NCT06122987
- Acronym / sponsor ID
- KRMC 0284
- Conditions
- Septic Shock, Shock, Sepsis, Systemic Inflammatory Response Syndrome
- Keywords
- Sepsis, Angiotensin II, Hydrocortisone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kingman Regional Medical CenterUniversity, hospital or other
- Collaborators
- La Jolla Pharmaceutical Company
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Norepinephrine is a catecholamine that is the first-line vasopressor for septic shock. The addition of non-catecholamine vasopressors, including vasopressin and angiotensin-II may be used in adults with septic shock that have inadequate mean arterial pressure while on norepinephrine. Uncertainty exists regarding the timing of initiation of these agents and there is a lack of data comparing their safety and efficacy.
The current literature suggests that earlier initiation of angiotensin-II will have a more significant reduction on norepinephrine-equivalent dose compared to later initiation. In addition, approximately half of patients initiated on vasopressin do not have an early hemodynamic response 6 hours after initiation. The purpose of this study is to evaluate the efficacy of angiotensin-II when used as the second vasopressor agent for septic shock.
Detailed description
Objectives:
Primary Objective:
- To evaluate the efficacy of ang-II when used as the second vasopressor agent for septic shock
Secondary Objectives:
- To assess the duration of response to ang-II
- To assess overall survival
- To assess the amount of time spent in the ICU
- To assess the need for renal replacement therapy
- To assess the overall duration of vasoactive medication use
- To assess toxicity and tolerability
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Angiotensin II and hydrocortisone sodium succinateDrug: Angiotensin II Other Names: Giapreza |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to the ICU within 12 hours of presentation to the emergency department for septic shock requiring 15-25 mcg/min of norepinephrine. Septic shock will be defined as having a known or presumed infection with two or more criteria of systemic inflammatory response syndrome, a mean arterial pressure <65 mm Hg despite fluid resuscitation requiring vasopressor support, and a serum lactate >2 mmol/L. Criteria of systemic inflammatory response syndrome include a temperature >100.4°F or <96.8°F; heart rate >90/min; respiratory rate >20/min and a white blood cell count >12,000/mm3 or <4,000/mm3.
Key exclusion criteria (6 listed)
- Age <18 years
- Pregnancy or lactation
- Known allergic reactions to angiotensin-II or hydrocortisone sodium succinate
- Requiring >25 mcg/min of norepinephrine or on any vasopressor other than norepinephrine at study enrollment
- Clinically significant bleeding precluding the use of chemical prophylaxis for venous thromboembolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiotensin II and hydrocortisone sodium succinateAlso: GiaprezaIntravenous infusion angiotensin II (titrated for each individual patient by effect) and hydrocortisone 50 mg intravenous bolus every 6 hours. | Drug | Single Arm |
Primary outcome
The incidence of hemodynamic response, defined as a decrease in norepinephrine-equivalent dose with a MAP ≥65 mm Hg at 1 hour after initiation of angiotensin-II
Time frame: 1 hour
Defined as a decrease in norepinephrine-equivalent dose with a MAP ≥65 mm Hg at 1 hour after initiation of angiotensin-II.
7 secondary outcomes
The incidence of hemodynamic response at 3 hours after initiation of angiotensin-II
Time frame: 3 hours
The incidence of hemodynamic response at 6 hours after initiation of angiotensin-II
Time frame: 6 hours
28-day mortality
Time frame: 28 days
ICU length of stay
Time frame: 1 year
Need for renal replacement therapy
Time frame: 1 year
Vasoactive medication duration overall
Time frame: 1 year
Incidence of adverse reactions
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
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
Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
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.
Tyson Dietrich, PharmD principal investigator
Kingman Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Angiotensin II and hydrocortisone sodium succinate in people with Septic Shock and Shock, run by Kingman Regional 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 May 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tyson Dietrich, PharmD (928-263-3933, TDietrich@azkrmc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of hemodynamic response, defined as a decrease in norepinephrine-equivalent dose with a MAP ≥65 mm Hg at 1 hour after initiation of angiotensin-II (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2024.