HypotensionEarly Phase 1NCT04463394
The Hemodynamic Effects of Vasopressin in Patients With Fontan Physiology
A Early Phase 1 study testing Vasopressin in people with Hypotension and Fontan Physiology, run by Stanford University at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypotension, Fontan Physiology
- What is being tested?
- Vasopressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Aug 2020to 15 Feb 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. All patients scheduled for cardiac catheterization at Lucile Packard Children's Hospital with Fontan circulation
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford University Medical Center
Stanford, California, 94305
Stanford University
Stanford, California, 94305
About this study
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.
Read the detailed 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.
- Conditions
- Hypotension, Fontan Physiology
- Being tested
- Vasopressin
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasopressinDrug
Vasopressin administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Vasopressin | Experimental | Participants undergoing cardiac catheterization Receives: Drug: Vasopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systemic (aortic) blood pressure
Measured: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)
Change in pulmonary artery pressure
Measured: 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
Measured: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)
PVR/SVR Ratio
Measured: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start12 Aug 2020
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manchula Navaratnam, Stanford University
- Investigators
- Manchula Navaratnam, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463394
- Sponsor's protocol ID
- 56875
- Status last verified
- May 2025
- First submitted
- 29 Jun 2020
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27144689Kumar 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.
PubMed 26714993Bigelow 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.
PubMed 31400337Adamson 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.
PubMed 37462430
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hemodynamic Effects of Vasopressin in Patients With Fontan Physiology
- ClinicalTrials.gov ID
- NCT04463394
- Acronym / sponsor ID
- 56875
- Conditions
- Hypotension, Fontan Physiology
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vasopressin | Experimental | Drug: VasopressinParticipants undergoing cardiac catheterization |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. All patients scheduled for cardiac catheterization at Lucile Packard Children's Hospital with Fontan circulation
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VasopressinVasopressin administered intravenously | Drug | Vasopressin |
Primary outcome
Change in systemic (aortic) blood pressure
Time frame: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)
Change in pulmonary artery pressure
Time frame: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)
Change in transpulmonary gradient
Time frame: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)
Transpulmonary gradient = Mean pulmonary arterial pressure - left atrial pressure
PVR/SVR Ratio
Time frame: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Background: PubMed 27144689Siehr 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.
- Background: PubMed 26714993Kumar 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.
- Background: PubMed 31400337Bigelow 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.
- Results publication: PubMed 37462430Adamson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manchula Navaratnam, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vasopressin in people with Hypotension and Fontan Physiology, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systemic (aortic) blood pressure (time frame: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04463394, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.