Septic ShockPhase 4NCT05193370

Angiotensin II vs. Vasopressin in Septic Shock

A Phase 4 study testing Angiotensin II and Vasopressin in people with Septic Shock, run by University of New Mexico at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This will be a randomized controlled unblinded pragmatic single-center pilot trial of the use of vasopressin vs. angiotensin II as a second-line vasopressor in patients with septic shock and persistent hypotension despite moderate-to-high doses of norepinephrine. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Septic Shock
What is being tested?: Angiotensin II and Vasopressin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 3 Jan 2022to 30 Nov 2022
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

1. Adult patients ≥18 years-old with vasodilatory shock refractory to norepinephrine monotherapy, defined as those who require ≥0.2 mcg/kg/min to maintain a MAP between 65-70 mmHg. Patients will be screened once they require ≥0.1 mcg/kg/min of norepinephrine and, if eligible, may be consented at this point. Study drug (angiotensin II or vasopressin) will be initiated once norepinephrine dose reaches ≥0.2 mcg/kg/min for at least 30 minutes.
2. Patients are required to have central venous and arterial catheters present, and they are expected to remain in place for at least the initial 72 hours of study.
3. Patients are required to have an indwelling urinary catheter present, and it is expected to remain in place for at least the 72 hours of study.
4. Patients must have received 20-30 mL/kg of crystalloid over the previous 24-hour period, as clinically appropriate, and no longer be fluid responsive as per UNMH protocol. By UNMH protocol, lack of fluid responsiveness is considered a failure to increase stroke volume, stroke volume index, cardiac output, or cardiac index (typically measured by non-calibrated pulse contour analysis using a FloTrac device) by at least 10% after a 500-mL crystalloid bolus or a passive leg raise. Patients for whom the treating physicians feel that 20 mL/kg of crystalloid may be clinically inappropriate can qualify for the study if the reason for withholding further IV fluids is documented.
5. Patient or (in patients unable to consent) legal authorized representative (LAR) is willing and able to provide written informed consent and comply with all protocol requirements.
6. Approval from the attending physician and clinical pharmacist conducting the study.

Who cannot join

1. Patients who are < 18 years of age.
2. Patients diagnosed with acute occlusive coronary syndrome requiring intervention and/or cardiogenic shock.
3. Patients with or suspected to have abdominal aortic aneurysm or aortic dissection.
4. Acute stroke.
5. Patients with acute mesenteric ischemia or those with a history of mesenteric ischemia.
6. Patients with known Raynaud's phenomenon, systemic sclerosis, or vasospastic disease.

Show all 21Show fewer

7. Patients on veno-arterial (VA) ECMO.
8. Patients with liver failure with a Model for End-Stage Liver Disease (MELD) score of ≥30.
9. Patients with burns covering >20% of total body surface area.
10. Patients with a history of asthma or COPD with active acute bronchospasm or (if not mechanically ventilated) with an acute exacerbation of their asthma/COPD requiring the use of inhaled bronchodilators.
11. Patients requiring more than 500 mg daily of hydrocortisone or equivalent glucocorticoid medication as a standing dose.
12 Patients with an absolute neutrophil count (ANC) of < 1,000/mm3.
13. Patients with hemorrhagic shock OR active bleeding AND an anticipated need (within 48 hours of initiation of the study) for transfusion of >4 units of packed red blood cells.
14. Patients with active bleeding AND hemoglobin < 7g/dL or any other condition that would contraindicate serial blood sampling.
15. Untreated venous thromboembolism (VTE) or inability to tolerate pharmacologic VTE prophylaxis.
16. Patients with a known allergy to mannitol.
17. Patients with an expected survival of <24 hours, SOFA score ≥ 16, or death deemed to be imminent or inevitable during the admission
18. Either the attending physician or patient and/or substitute decision-maker are not committed to all active treatment (e.g., DNR status).
19. Patients who are known to be pregnant at the time of screening. [All women ≤50 years-old will need a negative serum pregnancy test (serum quantitative beta-hCG) to enroll.]
20. Prisoner status
21. Patients who are current participating in another interventional clinical trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87106

Other trials in United States

About this study

Official title: A Randomized Controlled Pilot Trial of Angiotensin II Versus Vasopressin as Second-line Vasopressor in the Treatment of Septic Shock

Read the detailed description

Sepsis affects >1 million Americans yearly and, when septic shock ensues, is associated with high morbidity and mortality. Though first-line norepinephrine is standard of care, there are limited prospective data to guide the choice of additional vasopressors in septic shock. While more studies are needed, preliminary data suggest that the vasopressor angiotensin II (AngII) may improve outcomes in septic shock.

This study is a pilot randomized controlled trial (RCT) comparing AngII (intervention) and vasopressin (standard of care) as second-line vasopressors in septic shock. The goal is to demonstrate feasibility of a large multicenter RCT and eventually to demonstrate that AngII use improves important endpoints (e.g., mortality, need for organ support) in all or certain subsets of patients with septic shock.

Furthermore, there are no biomarkers currently available and validated to guide the choice of vasopressor therapy in septic shock. In this study the investigators will investigate serum renin as such a biomarker. Renin has been shown in preliminary studies to accurately predict mortality in septic shock, outperforming lactate, and to predict beneficial response to AngII. The investigators aim to validate the use of renin as a biomarker in septic shock and prove its utility in guiding vasopressor selection, with the goal of incorporating renin levels at specified time points and/or change in renin levels into an algorithm used to select patients for AngII therapy in the subsequent large multicenter RCT.

Conditions: Septic Shock
Being tested: Angiotensin II, Vasopressin
Keywords: septic shock, vasopressor, angiotensin II, vasopressin, renin, randomized controlled trial
Medical subject headings: Shock, Septic, Diabetes Insipidus

What participants receive

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

Angiotensin IIDrug
Also called Giapreza
Angiotensin II (Giapreza) is a pharmacologic version of a naturally occurring hormone of the same name, peptide hormone of the renin-angiotensin-aldosterone system (RAAS), that was FDA-approved in 2017 as a vasoconstrictive agent in the treatment of vasodilatory shock.
VasopressinDrug
Also called Vasostrict
Vasopressin (Vasostrict) is a pharmacologic version of a naturally occurring peptide hormone that serves as a vasoconstrictive agent in the treatment of vasodilatory shock.

Study groups in NCT05193370
Study group	Role	What they receive
angiotensin II (intervention)	Experimental	For patients randomized to the intervention group, once the dose of background norepinephrine reaches ≥0.2 mcg/kg/min for ≥30 minutes, angiotensin II will be started at a dose of 20 ng/kg/min (recommended starting dose in package insert). Thereafter, angiotensin II and norepinephrine will both be titrated according to the schema in UNM Hospitals Nursing Department Titration Guideline. Angiotensin II treatment will be capped at 72h, at which point (if a second vasopressor is still needed) the patient will be started on an alternative agent. Receives: Drug: Angiotensin II
vasopressin (standard of care)	Active comparator	In patients randomized to the control group, once the dose of background norepinephrine reaches ≥0.2 mcg/kg/min for ≥30 minutes, vasopressin will be used at a fixed dose of 0.04 units/min and norepinephrine will be titrated per usual standard of care (as also outlined in the UNM Hospitals Nursing Department Titration Guideline). Receives: Drug: Vasopressin

What is being measured

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

Percentage of patients who achieve blood pressure (BP) goal (MAP ≥65 mmHg) at 3 hours post-drug initiation
The primary endpoint will be the percentage of patients who achieve BP goal, specifically mean arterial pressure (MAP) of ≥65 mmHg, at the 3-hour time point. The primary endpoint will be binary (yes/no achievement of BP goal). Failure to respond to study drug will defined as any of the following: (1) MAP <65 mmHg at 3 hours, (2) Need for increase in background norepinephrine to >0.2 mcg/kg/min despite the addition of the study drug, or (3) Need for a third vasopressor.
Measured: 3 hours

Secondary outcomes (14)

BP goal at other time points
The primary endpoint will be re-assessed at multiple additional time points (1 hour, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours)
Measured: Up to 72 hours
Time to shock reversal
Time to sustained shock reversal (vasopressor independence).
Measured: Up to 72 hours
Change in catecholamine dose
Change in catecholamine dose (as quantified in norepinephrine equivalents) at 1 hour, 3 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours.
Measured: Up to 72 hours
SOFA score
Change in Sequential Organ Failure Assessment (SOFA) scores and/or organ-specific SOFA sub-scores at 1 hour, 3 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours. SOFA ranges from 0 to 24 with higher score indicating higher illness severity.
Measured: Up to 72 hours
Acute Kidney Injury (AKI)
Frequency of AKI, as defined by KDIGO (Kidney Disease: Improving Global Outcomes) criteria.
Measured: Up to 28 days
Freedom from Renal Replacement Therapy (RRT)
Days free from RRT (in first 28 days post study drug initiation)
Measured: Up to 28 days
Ventilator-free days
Days free from invasive mechanical ventilation (in first 28 days post drug initiation)
Measured: Up to 28 days
ICU LOS
ICU length of stay
Measured: Though study completion, up to 1 year
Hospital LOS
Hospital length of stay
Measured: Though study completion, up to 1 year
ICU mortality
ICU mortality (defined as binary yes/no, until ICU discharge or 28 days from drug initiation)
Measured: Up to 28 days
Hospital mortality
Hospital mortality (defined as binary yes/no, until hospital discharge or 28 days from drug initiation)
Measured: Up to 28 days
Renin levels
Renin levels will be obtained at 4 times points: at consent/pre-baseline; at baseline/time 0 (drug initiation); 1 hour post-initiation; and 3 hours post-initiation. The investigators will also perform exploratory analyses of differences in the primary and secondary outcomes as stratified by renin levels and/or changes in renin level.
Measured: Up to 3 hours
Subgroup analyses
The investigators will perform exploratory analyses of the other primary and secondary outcomes as stratified by disease severity (as measured by SOFA scores).
All the other primary and secondary outcomes will be also re-analyzed to assess for differences within the following subgroups:
- presence or absence of AKI
- presence or absence of ARDS
Measured: Though study completion, up to 1 year
Prespecified Adverse Events
For these to be considered adverse events (AEs) they must be new hospital-acquired events which developed after randomization.
The pre-defined AEs that will be tracked will include the rates of:
- New venous thromboembolism (VTE) or arterial thrombosis diagnosed during hospital stay.
- Atrial fibrillation
- Tachycardia
- Lactic acidosis
- Peripheral limb/digit ischemia
- Intestinal ischemia
- Thrombocytopenia
- Hyperglycemia
- Confirmed infection (with infecting organism confirmed by culture or other identification method; administration of appropriate antibiotic therapy; and clinical documentation of infection)
- Any other AE that is felt to be potentially related to study drug
Measured: Up to 28 days

Timeline

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

3 Jan 202230 Nov 2022

First posted14 Jan 2022
Study start3 Jan 2022 (estimated)
Primary completion30 Nov 2022 (estimated)
Study completion30 Nov 2022 (estimated)

Why it stopped: Funding and protocol changes. Replaced with new pilot trial.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Parallel groups
Model description: single-center, open-label pragmatic randomized controlled pilot trial using block randomization
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05193370
Sponsor's protocol ID: 21-040
Other IDs: UL1TR001449
Status last verified: Mar 2024
First submitted: 9 Dec 2021
Last updated: 15 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Khanna A, English SW, Wang XS, Ham K, Tumlin J, Szerlip H, Busse LW, Altaweel L, Albertson TE, Mackey C, McCurdy MT, Boldt DW, Chock S, Young PJ, Krell K, Wunderink RG, Ostermann M, Murugan R, Gong MN, Panwar R, Hastbacka J, Favory R, Venkatesh B, Thompson BT, Bellomo R, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Deane AM; ATHOS-3 Investigators. Angiotensin II for the Treatment of Vasodilatory Shock. N Engl J Med. 2017 Aug 3;377(5):419-430. doi: 10.1056/NEJMoa1704154. Epub 2017 May 21.
PubMed 28528561
Tumlin JA, Murugan R, Deane AM, Ostermann M, Busse LW, Ham KR, Kashani K, Szerlip HM, Prowle JR, Bihorac A, Finkel KW, Zarbock A, Forni LG, Lynch SJ, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Bellomo R; Angiotensin II for the Treatment of High-Output Shock 3 (ATHOS-3) Investigators. Outcomes in Patients with Vasodilatory Shock and Renal Replacement Therapy Treated with Intravenous Angiotensin II. Crit Care Med. 2018 Jun;46(6):949-957. doi: 10.1097/CCM.0000000000003092.
PubMed 29509568
Gordon AC, Mason AJ, Thirunavukkarasu N, Perkins GD, Cecconi M, Cepkova M, Pogson DG, Aya HD, Anjum A, Frazier GJ, Santhakumaran S, Ashby D, Brett SJ; VANISH Investigators. Effect of Early Vasopressin vs Norepinephrine on Kidney Failure in Patients With Septic Shock: The VANISH Randomized Clinical Trial. JAMA. 2016 Aug 2;316(5):509-18. doi: 10.1001/jama.2016.10485.
PubMed 27483065
Busse L, Albertson T, Gong M. Outcomes in patients with acute respiratory distress syndrome receiving angiotensin II for vasodilatory shock. Crit Care. 2018;22(Suppl 1):82.
Gleeson PJ, Crippa IA, Mongkolpun W, Cavicchi FZ, Van Meerhaeghe T, Brimioulle S, Taccone FS, Vincent JL, Creteur J. Renin as a Marker of Tissue-Perfusion and Prognosis in Critically Ill Patients. Crit Care Med. 2019 Feb;47(2):152-158. doi: 10.1097/CCM.0000000000003544.
PubMed 30653055
Bellomo R, Forni LG, Busse LW, McCurdy MT, Ham KR, Boldt DW, Hastbacka J, Khanna AK, Albertson TE, Tumlin J, Storey K, Handisides D, Tidmarsh GF, Chawla LS, Ostermann M. Renin and Survival in Patients Given Angiotensin II for Catecholamine-Resistant Vasodilatory Shock. A Clinical Trial. Am J Respir Crit Care Med. 2020 Nov 1;202(9):1253-1261. doi: 10.1164/rccm.201911-2172OC.
PubMed 32609011

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

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All Septic Shock trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Pilot Trial of Angiotensin II Versus Vasopressin as Second-line Vasopressor in the Treatment of Septic Shock
ClinicalTrials.gov ID: NCT05193370
Acronym / sponsor ID: 21-040
Conditions: Septic Shock
Keywords: septic shock, vasopressor, angiotensin II, vasopressin, renin, randomized controlled trial
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Funding and protocol changes. Replaced with new pilot trial.
Enrolment: 0 participants (actual)
Lead sponsor: University of New MexicoUniversity, hospital or other
Collaborators: La Jolla Pharmaceutical Company, National Center for Advancing Translational Sciences (NCATS)
Study start: 3 Jan 2022 (estimated)
Primary completion: 30 Nov 2022 (estimated)
Study completion: 30 Nov 2022 (estimated)
First posted: 14 Jan 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: single-center, open-label pragmatic randomized controlled pilot trial using block randomization

Arm	Type	Receives
angiotensin II (intervention)	Experimental	Drug: Angiotensin IIFor patients randomized to the intervention group, once the dose of background norepinephrine reaches ≥0.2 mcg/kg/min for ≥30 minutes, angiotensin II will be started at a dose of 20 ng/kg/min (recommended starting dose in package insert). Thereafter, angiotensin II and norepinephrine will both be titrated according to the schema in UNM Hospitals Nursing Department Titration Guideline. Angiotensin II treatment will be capped at 72h, at which point (if a second vasopressor is still needed) the patient will be started on an alternative agent.
vasopressin (standard of care)	Active comparator	Drug: VasopressinIn patients randomized to the control group, once the dose of background norepinephrine reaches ≥0.2 mcg/kg/min for ≥30 minutes, vasopressin will be used at a fixed dose of 0.04 units/min and norepinephrine will be titrated per usual standard of care (as also outlined in the UNM Hospitals Nursing Department Titration Guideline).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

1. Adult patients ≥18 years-old with vasodilatory shock refractory to norepinephrine monotherapy, defined as those who require ≥0.2 mcg/kg/min to maintain a MAP between 65-70 mmHg. Patients will be screened once they require ≥0.1 mcg/kg/min of norepinephrine and, if eligible, may be consented at this point. Study drug (angiotensin II or vasopressin) will be initiated once norepinephrine dose reaches ≥0.2 mcg/kg/min for at least 30 minutes.
2. Patients are required to have central venous and arterial catheters present, and they are expected to remain in place for at least the initial 72 hours of study.
3. Patients are required to have an indwelling urinary catheter present, and it is expected to remain in place for at least the 72 hours of study.
4. Patients must have received 20-30 mL/kg of crystalloid over the previous 24-hour period, as clinically appropriate, and no longer be fluid responsive as per UNMH protocol. By UNMH protocol, lack of fluid responsiveness is considered a failure to increase stroke volume, stroke volume index, cardiac output, or cardiac index (typically measured by non-calibrated pulse contour analysis using a FloTrac device) by at least 10% after a 500-mL crystalloid bolus or a passive leg raise. Patients for whom the treating physicians feel that 20 mL/kg of crystalloid may be clinically inappropriate can qualify for the study if the reason for withholding further IV fluids is documented.
5. Patient or (in patients unable to consent) legal authorized representative (LAR) is willing and able to provide written informed consent and comply with all protocol requirements.

Key exclusion criteria (21 listed)

1. Patients who are < 18 years of age.
2. Patients diagnosed with acute occlusive coronary syndrome requiring intervention and/or cardiogenic shock.
3. Patients with or suspected to have abdominal aortic aneurysm or aortic dissection.
4. Acute stroke.
5. Patients with acute mesenteric ischemia or those with a history of mesenteric ischemia.

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 IIAlso: GiaprezaAngiotensin II (Giapreza) is a pharmacologic version of a naturally occurring hormone of the same name, peptide hormone of the renin-angiotensin-aldosterone system (RAAS), that was FDA-approved in 2017 as a vasoconstrictive agent in the treatment of vasodilatory shock.	Drug	angiotensin II (intervention)
VasopressinAlso: VasostrictVasopressin (Vasostrict) is a pharmacologic version of a naturally occurring peptide hormone that serves as a vasoconstrictive agent in the treatment of vasodilatory shock.	Drug	vasopressin (standard of care)

Primary outcome

Percentage of patients who achieve blood pressure (BP) goal (MAP ≥65 mmHg) at 3 hours post-drug initiation
Time frame: 3 hours
The primary endpoint will be the percentage of patients who achieve BP goal, specifically mean arterial pressure (MAP) of ≥65 mmHg, at the 3-hour time point. The primary endpoint will be binary (yes/no achievement of BP goal). Failure to respond to study drug will defined as any of the following: (1) MAP <65 mmHg at 3 hours, (2) Need for increase in background norepinephrine to >0.2 mcg/kg/min despite the addition of the study drug, or (3) Need for a third vasopressor.

14 secondary outcomes

BP goal at other time points
Time frame: Up to 72 hours
Time to shock reversal
Time frame: Up to 72 hours
Change in catecholamine dose
Time frame: Up to 72 hours
SOFA score
Time frame: Up to 72 hours
Acute Kidney Injury (AKI)
Time frame: Up to 28 days
Freedom from Renal Replacement Therapy (RRT)
Time frame: Up to 28 days
Ventilator-free days
Time frame: Up to 28 days
ICU LOS
Time frame: Though study completion, up to 1 year
Hospital LOS
Time frame: Though study completion, up to 1 year
ICU mortality
Time frame: Up to 28 days
Hospital mortality
Time frame: Up to 28 days
Renin levels
Time frame: Up to 3 hours
Subgroup analyses
Time frame: Though study completion, up to 1 year
Prespecified Adverse Events
Time frame: Up to 28 days

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Background: PubMed 28528561Khanna A, English SW, Wang XS, Ham K, Tumlin J, Szerlip H, Busse LW, Altaweel L, Albertson TE, Mackey C, McCurdy MT, Boldt DW, Chock S, Young PJ, Krell K, Wunderink RG, Ostermann M, Murugan R, Gong MN, Panwar R, Hastbacka J, Favory R, Venkatesh B, Thompson BT, Bellomo R, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Deane AM; ATHOS-3 Investigators. Angiotensin II for the Treatment of Vasodilatory Shock. N Engl J Med. 2017 Aug 3;377(5):419-430. doi: 10.1056/NEJMoa1704154. Epub 2017 May 21.
Background: PubMed 29509568Tumlin JA, Murugan R, Deane AM, Ostermann M, Busse LW, Ham KR, Kashani K, Szerlip HM, Prowle JR, Bihorac A, Finkel KW, Zarbock A, Forni LG, Lynch SJ, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Bellomo R; Angiotensin II for the Treatment of High-Output Shock 3 (ATHOS-3) Investigators. Outcomes in Patients with Vasodilatory Shock and Renal Replacement Therapy Treated with Intravenous Angiotensin II. Crit Care Med. 2018 Jun;46(6):949-957. doi: 10.1097/CCM.0000000000003092.
Background: PubMed 27483065Gordon AC, Mason AJ, Thirunavukkarasu N, Perkins GD, Cecconi M, Cepkova M, Pogson DG, Aya HD, Anjum A, Frazier GJ, Santhakumaran S, Ashby D, Brett SJ; VANISH Investigators. Effect of Early Vasopressin vs Norepinephrine on Kidney Failure in Patients With Septic Shock: The VANISH Randomized Clinical Trial. JAMA. 2016 Aug 2;316(5):509-18. doi: 10.1001/jama.2016.10485.
BackgroundBusse L, Albertson T, Gong M. Outcomes in patients with acute respiratory distress syndrome receiving angiotensin II for vasodilatory shock. Crit Care. 2018;22(Suppl 1):82.
Background: PubMed 30653055Gleeson PJ, Crippa IA, Mongkolpun W, Cavicchi FZ, Van Meerhaeghe T, Brimioulle S, Taccone FS, Vincent JL, Creteur J. Renin as a Marker of Tissue-Perfusion and Prognosis in Critically Ill Patients. Crit Care Med. 2019 Feb;47(2):152-158. doi: 10.1097/CCM.0000000000003544.
Background: PubMed 32609011Bellomo R, Forni LG, Busse LW, McCurdy MT, Ham KR, Boldt DW, Hastbacka J, Khanna AK, Albertson TE, Tumlin J, Storey K, Handisides D, Tidmarsh GF, Chawla LS, Ostermann M. Renin and Survival in Patients Given Angiotensin II for Catecholamine-Resistant Vasodilatory Shock. A Clinical Trial. Am J Respir Crit Care Med. 2020 Nov 1;202(9):1253-1261. doi: 10.1164/rccm.201911-2172OC.
Individual participant dataSharing planned: No

Related trials for Septic Shock

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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.

Joao P Teixeira, MD principal investigator

University of New Mexico School of Medicine

Nathan D Nielsen, MD MSc principal investigator

University of New Mexico School of Medicine

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 Vasopressin in people with Septic Shock, run by University of New Mexico 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 6 inclusion and 21 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: withdrawn, as of the sponsor's last update on 15 Mar 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Percentage of patients who achieve blood pressure (BP) goal (MAP ≥65 mmHg) at 3 hours post-drug initiation (time frame: 3 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 NCT05193370, which also lists 6 linked publications.

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 15 Mar 2024.