RECRUITING

Early Versus Late Adjunctive Vasopressin in Septic Shock

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of the CASPER-Pilot study is to develop clinical decision support (CDS) technology within Epic to randomize patients with septic shock to early versus standard of care vasopressin initiation. The primary aim of this study will be to test the hypothesis that CDS technology can be utilized to create two distinct cohorts of patients reflecting different times of vasopressin initiation based on norepinephrine dose requirements. Secondarily, this study will evaluate the proportion of patients whose norepinephrine dose at the time of vasopressin initiation is within the specified range for the intervention arm they were randomized to. Other outcomes of evaluation will include adherence to the developed CDS technology and comparison of clinical outcomes between the two treatment arms.

Official Title

Clinical Decision Support Assistance to Randomize Patients to Early or Late Adjunctive Vasopressin in Septic Shock

Quick Facts

Study Start:2025-04-29
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06709573

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 Years
  2. * Diagnosis of Septic Shock
  3. * Admitted to Cleveland Clinic Main Campus Medical ICU
  4. * Receiving continuous infusion of norepinephrine at a dose \> 5 mcg/min at time of enrollment
  1. * Administration of any other vasoactive agent other than norepinephrine at time of enrollment
  2. * Initiation of vasopressin by provider outside of the context of study when NE \< 10 mcg/min (before BPA firing)

Contacts and Locations

Study Contact

Gretchen L. Sacha, PharmD
CONTACT
216-379-4237
sachag@ccf.org
Abhijit Duggal, MD
CONTACT
216-444-4838
duggala2@ccf.org

Principal Investigator

Gretchen L. Sacha, PharmD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic
Cleveland, Ohio, 44095
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Gretchen L. Sacha, PharmD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-29
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-04-29
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Sepsis
  • Septic Shock
  • Vasopressors
  • Vasopressin

Additional Relevant MeSH Terms

  • Sepsis
  • Septic Shock