Phase 3
N=153
Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients:
Cardiac Disease
Bottom Line
View on ClinicalTrials.gov: NCT04501861 ↗Enrolled (actual)
153
Serious AEs
—
Results posted
Jan 2025
Primary outcome: Primary: mPAP-to-MAP Ratio — 0.394; 0.385; 0.42; 0.40 ratio of mPAP-to-MAP — p=0.53
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vasopressin (Drug); Norepinephrine (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY mPAP-to-MAP Ratio |
0.394; 0.385; 0.42; 0.40; 0.37; 0.36 | 0.53 |
| SECONDARY RV Free Wall Strain |
-18.2; -19.4; -17.5; -18.9; -19.2; -20.0 | 0.37 |
Summary
The relative increase in the mPAP with the same unit increase in MAP adjusted for baseline, and RV function assessed by GLS, between VP and NE in patients with normal and increased pulmonary artery pressure, who require vasopressor support during cardiac surgery.
Eligibility Criteria
Inclusion criteria
Adults> 18 years of age
- Elective cardiac surgery with the use of CPB
- Patients with pulmonary artery catheter insertion
- Systemic hypotension (MAP < 70 mmHg) requiring continuous infusion of vasopressor
Exclusion Criteria
- Transplant surgery
- Ventricular assist device implantation other than intra-aortic balloon counter-pulsation
- Pulmonary endarterectomy
- Thoracoabdominal aneurysm repair
- Inhalational pulmonary vasodilators (e.g. Epoprostenol) administration before insertion of pulmonary artery catheter
- Vasopressin is started as the first choice of pressor per clinical staff discretion
Data sourced from ClinicalTrials.gov (NCT04501861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.