Angiotensin II vs. Vasopressin in Septic Shock

Status Withdrawn

Clinical 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05193370
Study type	Interventional
Source	University of New Mexico
Contact
Status	Withdrawn
Phase	Phase 4
Start date	January 3, 2022
Completion date	November 30, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03649633` - Vitamin C, Steroids, and Thiamine, and Cerebral Autoregulation and Functional Outcome in Septic Shock	Phase 1/Phase 2
Terminated	`NCT04117568` - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed	`NCT04227652` - Control of Fever in Septic Patients	N/A
Completed	`NCT05629780` - Temporal Changes of Lactate in CLASSIC Patients	N/A
Recruiting	`NCT04796636` - High-dose Intravenous Vitamin C in Patients With Septic Shock	Phase 1
Terminated	`NCT03335124` - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock	Phase 4
Recruiting	`NCT04005001` - Machine Learning Sepsis Alert Notification Using Clinical Data	Phase 2
Recruiting	`NCT05217836` - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Recruiting	`NCT05066256` - LV Diastolic Function vs IVC Diameter Variation as Predictor of Fluid Responsiveness in Shock	N/A
Not yet recruiting	`NCT05443854` - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)	Phase 3
Not yet recruiting	`NCT04516395` - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae	N/A
Recruiting	`NCT02899143` - Short-course Antimicrobial Therapy in Sepsis	Phase 2
Recruiting	`NCT02676427` - Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination
Recruiting	`NCT02580240` - Administration of Hydrocortisone for the Treatment of Septic Shock	N/A
Recruiting	`NCT02565251` - Volemic Resuscitation in Sepsis and Septic Shock	N/A
Not yet recruiting	`NCT02547467` - TOADS Study: TO Assess Death From Septic Shock.	N/A
Completed	`NCT02638545` - Hemodynamic Effects of Dexmedetomidine in Septic Shock	Phase 3
Terminated	`NCT02335723` - ASSET - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber	N/A
Completed	`NCT02079402` - Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care	Phase 4
Completed	`NCT02204852` - Co-administration of Iloprost and Eptifibatide in Septic Shock Patients	Phase 2