Home
Clinical Trials
Efficacy and Safety of Angiot...

Efficacy and Safety of Angiotensin II Injection Versus Placebo in Patients With Refractory Distributed Shock

Last Updated: 2025-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-23

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A randomized, double-blind, placebo-controlled study on the treatment of refractory distributed shock with angiotensin II injection, with a random ratio of 1:1. Assuming a success rate of 25% for the main therapeutic endpoint in the control group and 50% for the experimental group, a total of 214 subjects will be enrolled, including 107 in the experimental group and 107 in the control group.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fixed-dose Combination of an Angiotensin Receptor Blocker and Thiazide Diuretic for Essential Hypertension

NCT06608472

Essential Arterial Hypertension

NOT_YET_RECRUITING PHASE3

Phase 1, Randomized, Double-Blind, Placebo-Controlled Exploratory Study That Will Assess the Safety, Tolerability, Pharmacokinetics and Hemodynamic Response to a Single 30 Minute Intravenous Infusion of Vasomera™ (PB1046) in Adult Subjects With Stage 1 or 2 Essential Hypertension

NCT01873885

Essential Hypertension

COMPLETED PHASE1

TC-5214 as Augmentation Therapy in Patients With Refractory Hypertension

NCT00899977

Refractory Hypertension

TERMINATED PHASE1/PHASE2

Comparison of Blood Pressure Control Achieved in Antihypertensive or Generic Drugs in Moderate to Severe Hypertensive Patients

NCT02853045

Hypertension

COMPLETED PHASE4

A Study to Evaluate the Efficacy and Safety of Co-administration of AD-227A and AD-227B

NCT06441630

Essential Hypertension

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vasodilatory Shock

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Angiotensin Ⅱ Injection

Angiotensin II injection is administered via central vein, and the drug dosage is adjusted according to Mean Arterial Pressure (MAP), with an allowable dose of 1.25\~160 ng/kg/min. Maximum 168 h.

Group Type EXPERIMENTAL

Angiotensin II Injection

Intervention Type DRUG

1、Angiotensin II injection is a naturally occurring octapeptide hormone in the human renin angiotensin aldosterone system (RAAS). It is the main effector molecule of the RAAS system and one of the strongest known vasoconstrictors, involved in neurohumoral regulation.

Placebo

The placebo is administered via central vein, and the drug dosage is adjusted according to MAP, with an allowable dose of 1.25\~160 ng/kg/min. Maximum 168 h.

Group Type PLACEBO_COMPARATOR

0.9% sodium chloride injection

Intervention Type DRUG

0.9% sodium chloride injection, not containing active ingredients.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Angiotensin II Injection

Intervention Type DRUG

0.9% sodium chloride injection

0.9% sodium chloride injection, not containing active ingredients.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age: 18 years to 75 years old, male or female;
* diagnosis of distributive shock;
* on the basis of the treatment of total vasoactive drugs dose \> 0.2 μg/kg/min norepinephrine (or equivalent dose of another vasoactive drug: such as epinephrine \> 0.2 μg/kg/min, dopamine \> 30 μg/kg/min, phenylephrine \> 2 μg/kg/min, vasopressin \> 0.08 U/min) and continuous treatment for at least 6 hours and no more than 48 hours, the patient's mean arterial pressure can still only be maintained between 55 and 70 mmHg, or do not reach the target MAP assessed by clinicians, it can be diagnosed as refractory distributive shock.
* have central venous access and arterial catheters, and are expected to be present for at least the first 48 hours of the study.
* indwelling catheter, and expected to be present for at least the first 48 hours of the study.
* patient has received at least 30 mL/kg of crystalloid or colloid volume in the previous 24 hours or has undergone adequate volume resuscitation in the opinion of the investigator.
* patients must have one of the following criteria with clinical features of high-output shock

1. Central venous oxygen saturation (ScVO2) \> 70% (via saturation catheter or central venous blood gas) and central venous pressure (CVP) \> 8 mmHg.
2. cardiac index (CI) \> 2.3 L/min/m2.
* the patient or legal representative is willing and able to provide written informed consent and comply with all protocol requirements.

Exclusion Criteria

* Patients with burns \> 20% of total body surface area;
* Patients with cardiovascular (CV) SOFA score ≤ 3;
* Patients with acute coronary syndrome requiring interventional therapy;
* Patients treated with Extracorporeal Membrane Oxygenation (ECMO);
* Patients with end-stage liver failure (Model for end-stage liver disease score (MELD) \> 30).
* Patients with a diagnosis of asthma or bronchospasm.
* Patients with a diagnosis of acute mesenteric ischemia, or patients with suspected acute mesenteric ischemia.
* Patients with a history, presence, or high suspicion of aortic dissection or abdominal aortic aneurysm, or patients diagnosed with aortic dissection or abdominal aortic aneurysm.
* Patients who have been diagnosed with malignant tumor within the past 2 years, except for early malignant tumors (carcinoma in situ or stage I tumor) that have been radically treated or expected to recover after treatment, such as adequately treated thyroid cancer, cervical carcinoma in situ, basal cell or squamous cell carcinoma.
* Patients with Raynaud's phenomenon, systemic sclerosis or vasospastic disease.
* Patients with life expectancy ≤ 24 hours as assessed by the study physician.
* Patients with active bleeding who are expected to require transfusion of \> 4 units of packed red blood cells within 48 hours of study start.
* Patients with active bleeding and hemoglobin \< 7 g/dL or any other condition that contraindicates serial blood sampling.
* Patients with absolute neutrophil count (ANC) \< 1000 cells/mm3.
* Patients with known hypersensitivity to angiotensin II injection and its excipients.
* Patients who are currently participating in another interventional clinical trial.
* Blood/urine pregnancy test should be performed for patients with known pregnancy at screening and those with clinical suspicion of pregnancy.
* Patients who are considered unstable by the investigator or have any condition that would affect the safety of the study or the interpretation of the study results, or that would prevent the patient from completing the study, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical disorders. For example: patients with arrhythmia, uncontrolled hyperglycemia, cerebrovascular disease, uncontrolled hypertension, autoimmune disease requiring daily use of ≥ 500 mg hydrocortisone or equivalent glucocorticoids, etc.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers