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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID05139849

Randomized Study of Vasopressin and Steroids Added to Adrenaline for Adults Experiencing In-Hospital Cardiac Arrest

Led by Tiohundra AB · Updated on 2022-01-20

1276

Participants Needed

2

Research Sites

12 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a randomized, placebo-controlled, double-blind clinical trial to evaluate treatments for patients who experience in-hospital cardiac arrest and require adrenaline according to current guidelines. The study aims to determine whether adding vasopressin and steroids to adrenaline improves survival rates compared to adrenaline alone. The trial is expected to run for 3 to 4 years and will enroll about 1400 patients. Patients who have a cardiac arrest in the hospital and meet criteria for adrenaline administration will be randomly assigned to receive either adrenaline combined with vasopressin and steroids or adrenaline with a placebo sodium chloride. The intervention group receives vasopressin during CPR cycles and methylprednisolone during the first cycle, followed by hydrocortisone infusion for up to seven days in the ICU for those with post-resuscitation shock. The control group receives sodium chloride as a placebo during CPR and in the ICU at similar schedules. Participants will be monitored closely with survival at 30 days as the primary outcome measure. The study includes informed consent procedures for hospitalized men over 18 and women over 50 years old, excluding certain groups based on capacity to consent, pregnancy potential, and prior enrollment. The trial uses quadruple masking and randomization to ensure unbiased results, with data collected throughout the treatment and follow-up periods.

CONDITIONS

Brief Title

VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinical Trial

Research Team

S

Sune Forsberg, MD, PhD

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