The Hemodynamic Effects of Vasopressin in Patients With Fontan Physiology

NCT04463394 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 56875
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to evaluate if vasopressin can elevate systemic arterial blood pressures without having a significant effect on pulmonary arterial pressures. Because patients who have undergone Fontan procedures rely on low pressures across the pulmonary vascular bed to maintain cardiac output, vasoactive agents that concomitantly increase systemic and pulmonary pressures may have a deleterious effect in this specific patient population. Hypothesis: In patients with Fontan physiology, vasopressin will increase systemic BP by 20% above baseline, without increasing the transpulmonary gradient.

Conditions

Hypotension; Fontan Physiology

Outcome Measures

Primary Outcomes (4)

• Change in systemic (aortic) blood pressure

  Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)

• Change in pulmonary artery pressure

  Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)

• Change in transpulmonary gradient

  Transpulmonary gradient = Mean pulmonary arterial pressure - left atrial pressure

  Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)

• PVR/SVR Ratio

  Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)

Study Arms (1)

Vasopressin

EXPERIMENTAL

Participants undergoing cardiac catheterization

Drug: Vasopressin

Interventions

Vasopressin DRUG

Vasopressin administered intravenously

Vasopressin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. All patients scheduled for cardiac catheterization at Lucile Packard Children's Hospital with Fontan circulation

You may not qualify if:

• Critical illness severe enough to preclude extended cardiac catheterization time
• Patients already on vasopressin
• Patients with pulmonary hypertension.
• Patient not scheduled for cardiac catheterization at Lucile Packard Children's Hospital (LPCH).

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (4)

• Adamson GT, Yu J, Ramamoorthy C, Peng LF, Taylor A, Lennig M, Schmidt AR, Feinstein JA, Navaratnam M. Acute Hemodynamics in the Fontan Circulation: Open-Label Study of Vasopressin. Pediatr Crit Care Med. 2023 Nov 1;24(11):952-960. doi: 10.1097/PCC.0000000000003326. Epub 2023 Jul 18.

  PMID: 37462430 BACKGROUND

• Siehr SL, Feinstein JA, Yang W, Peng LF, Ogawa MT, Ramamoorthy C. Hemodynamic Effects of Phenylephrine, Vasopressin, and Epinephrine in Children With Pulmonary Hypertension: A Pilot Study. Pediatr Crit Care Med. 2016 May;17(5):428-37. doi: 10.1097/PCC.0000000000000716.

  PMID: 27144689 BACKGROUND

• Kumar TK, Kashyap P, Figueroa M, Zurakowski D, Allen J, Ballweg JA, Sathanandam S, Ali M, Knott-Craig CJ. Vasopressin After the Fontan Operation. World J Pediatr Congenit Heart Surg. 2016 Jan;7(1):43-8. doi: 10.1177/2150135115614574.

  PMID: 26714993 BACKGROUND

• Bigelow AM, Ghanayem NS, Thompson NE, Scott JP, Cassidy LD, Woods KJ, Woods RK, Mitchell ME, Hraska V, Hoffman GM. Safety and Efficacy of Vasopressin After Fontan Completion: A Randomized Pilot Study. Ann Thorac Surg. 2019 Dec;108(6):1865-1874. doi: 10.1016/j.athoracsur.2019.06.053. Epub 2019 Aug 7.

  PMID: 31400337 BACKGROUND

MeSH Terms

Conditions

Hypotension

Interventions

Vasopressins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular 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

• Manchula Navaratnam, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Anesthesiology

Model Details: Using Minimal Sample size estimation based on the primary outcome (PVR/SVR ratio) based on paired means for decreases in PVR/SVR ratio after vasopressin administration from a prior study at our institution. We calculated a minimum sample size of 28 for a power of 0.8 and and 0.05 significant difference.

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 9, 2020
• Study Start: August 12, 2020
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)