Early Versus Late Adjunctive Vasopressin in Septic Shock

NCT06709573 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 24-547
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis; Septic Shock

Keywords

Sepsis; Septic Shock; Vasopressors; Vasopressin

Outcome Measures

Primary Outcomes (1)

• Norepinephrine-equivalent dose

  The primary outcome is the norepinephrine-equivalent dose (in mcg/min) at the time of vasopressin initiation between patients who were randomized by CDS to early adjunctive vasopressin initiation compare to late adjunctive vasopressin initiation

  Outcome evaluated on day of vasopressin initiation

Secondary Outcomes (1)

• Proportion of patients within goal norepinephrine-equivalent dose range

  Outcome evaluated on day of vasopressin initiation

Other Outcomes (4)

• Hemodynamic Response

  6 hours after vasopressin initiation

• ICU mortality

  Through hospitalization admission

• In-hospital mortality

  Through hospitalization admission

Study Arms (2)

Early Vasopressin Initiation

EXPERIMENTAL

Patients randomized to this arm will have a provider BPA fire prompting vasopressin initiation when the norepinephrine dose is between 10-20 mcg/min

Drug: vasopressin - early initiation

Standard of Care Vasopressin Initiation

ACTIVE COMPARATOR

Patients randomized to this arm will have a provider BPA fire prompting vasopressin initiation when the norepinephrine dose is between 20-35 mcg/min

Drug: vasopressin - standard initiation

Interventions

vasopressin - early initiation DRUG

BPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 10-20 mcg/min

Also known as: vasopressin

Early Vasopressin Initiation

vasopressin - standard initiation DRUG

BPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 20-35 mcg/min

Also known as: vasopressin

Standard of Care Vasopressin Initiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 Years
• Diagnosis of Septic Shock
• Admitted to Cleveland Clinic Main Campus Medical ICU
• Receiving continuous infusion of norepinephrine at a dose \> 5 mcg/min at time of enrollment

You may not qualify if:

• Administration of any other vasoactive agent other than norepinephrine at time of enrollment
• Initiation of vasopressin by provider outside of the context of study when NE \< 10 mcg/min (before BPA firing)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44095, United States

RECRUITING

Related Publications (1)

• Sacha GL, Lam SW, Wang L, Duggal A, Reddy AJ, Bauer SR. Association of Catecholamine Dose, Lactate, and Shock Duration at Vasopressin Initiation With Mortality in Patients With Septic Shock. Crit Care Med. 2022 Apr 1;50(4):614-623. doi: 10.1097/CCM.0000000000005317.

  PMID: 34582425 RESULT

MeSH Terms

Conditions

Sepsis; Shock, Septic; Diabetes Insipidus

Interventions

Vasopressins

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Gretchen L. Sacha, PharmD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gretchen L. Sacha, PharmD

CONTACT

216-379-4237; sachag@ccf.org

Abhijit Duggal, MD

CONTACT

216-444-4838; duggala2@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 29, 2024
• Study Start: April 29, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)