The Hemodynamic Effects of Vasopressin in Patients With Fontan Physiology

Hypotension Clinical Trial

Official title:

The Hemodynamic Effects of Vasopressin in Patients With Fontan Physiology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04463394
• Other study ID #: 56875
• Status: Completed
• Phase: Early Phase 1
• Start date: August 12, 2020
• Est. completion date: February 15, 2022

Study information

• Verified date: April 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients with Fontan physiology are at increased risk of developing hypotension during periods of illness or with anesthesia. These patients have changes in venous capacitance, compliance, and venomotor tone. When hypotension occurs, the approach to management requires a careful understanding of these changes and the selection of appropriate, efficacious vasoactive agents. Vasoconstrictive medications are frequently used to treat hypotension when patients are refractory to fluid resuscitation. However, most of these medications have an effect on both the systemic and pulmonary circulations, raising the vascular pressures of both circuits. However, these patients often do not tolerate abrupt increases in pulmonary arterial pressures or vascular resistance, and a low transpulmonary gradient is imperative to maintain cardiac output. The ideal agent would be one that raises systemic vascular pressure while having a minimal effect on the pulmonary circulation. One promising medication for treating hypotension in Fontan patients is vasopressin. One prior study evaluated the hemodynamic effect of vasopressin in pediatric patients with pulmonary hypertension. Compared to other vasopressor agents (phenylephrine, epinephrine), vasopressin increased systemic blood pressure with the least effect on pulmonary artery pressure. In a second study evaluating the use of vasopressin specifically for patients undergoing cardiac surgery for the creation of a Fontan, those who were treated with vasopressin as part of their postoperative management demonstrated lower transpulmonary gradients than those treated with placebo. Other studies have evaluated the use of vasopressin in Fontan patients for other clinical outcomes, such as decreasing postoperative chest tube output. On the basis of these studies, as well as our clinical experience managing these patients in the operating room, procedural suites, and in the intensive care unit, the investigator believes that vasopressin is not only safe but may be the preferred agent for this patient population. Although vasopressin has been studied extensively in the context of sepsis, post cardiopulmonary bypass, and other vasoplegic disease states, the use of vasopressin has not yet been studied in the general population of patients who have Fontan physiology. The investigator hopes to demonstrate the efficacy of vasopressin as a medication specifically for these patients, as one that can elevate systemic blood pressure without compromising cardiac output or having a deleterious effect on the pulmonary vasculature.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion criteria:

1. Critical illness severe enough to preclude extended cardiac catheterization time

2. Patients already on vasopressin

3. Patients with pulmonary hypertension.

4. Patient not scheduled for cardiac catheterization at Lucile Packard Children's Hospital (LPCH).

Related Conditions & MeSH terms

• Fontan Physiology
• Hypotension

Intervention

Drug:
• Vasopressin
Vasopressin administered intravenously

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systemic (aortic) blood pressure		Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)
Primary	Change in pulmonary artery pressure		Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)
Primary	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)
Primary	PVR/SVR Ratio		Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)