Pleural EffusionPhase 2/3NCT02975999
Use of Vasopressin Following the Fontan Operation
A Phase 2/3 study testing Vasopressin and Normal Saline in people with Pleural Effusion and Single-ventricle, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this pilot study is to prepare for a larger study to determine whether Vasopressin following the Fontan operation will decrease chest tube output and duration. Read more about this study
- Who is it for?
- Ages 18 months to 7 years
- Conditions the study is for
- Pleural Effusion, Single-ventricle
- What is being tested?
- Vasopressin and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Dec 2019
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects between 1.5-7 years old undergoing Fontan operation.
Who cannot join
- Patients with a planned fenestrated Fontan.
- Patients undergoing revision surgery for failing Fontan.
- Evidence of renal insufficiency prior to surgery defined by creatinine >1 mg/dl.
- Planned arch reconstruction at the time of the Fontan procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Children's Hospital
Oak Lawn, Illinois, 60453
About this study
Official title: Use of Vasopressin Following the Fontan Operation: Both Pilot and Multicenter Studies
The purpose of this pilot study is to prepare for a larger study to determine whether Vasopressin following the Fontan operation will decrease chest tube output and duration.
Read the detailed description
A pilot randomized, double blinded clinical trial to evaluate the use of vasopressin following the Fontan operation.
Phase one of the study will be a single center pilot study and will be conducted at Advocate Children's Hospital, Oak Lawn IL. This will be a randomized and double blinded. Ten patients will be enrolled with five patients as control group and five receiving Vasopressin. Vasopressin levels will be obtained just prior to initiation of Vasopressin and 48 hours later in the pilot study. Safety and effect size will be evaluated after this pilot study.
Drug administration protocol:
Vasopressin at a dose of 0.4 mU/kg/min will be started on subjects in the study group while coming off cardiopulmonary bypass. The dose of Vasopressin will not be titrated. Study drug drip will infuse for 48 hours after which will be discontinued.
The placebo group will be receiving normal saline at the same rate of the vasopressin group. The treating physician will be blinded.
- Conditions
- Pleural Effusion, Single-ventricle
- Being tested
- Vasopressin, Normal Saline
- Medical subject headings
- Pleural Effusion, Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasopressinDrug
Also called Vasostrict, arginine
Vasopressin at dose of 0.4mU/kg/min will be started on the assigned group once coming off cardiopulmonary bypass following the Fontan operation.
Normal SalineDrug
Also called Placebo
Normal saline at starting dose of 0.4mU/kg/min will be started on the assigned group once coming off cardiopulmonary bypass following the Fontan operation.
| Study group | Role | What they receive |
|---|---|---|
| Vasopressin | Experimental | Vasopressin at 0.4mU/kg/min Receives: Drug: Vasopressin |
| Normal saline | Placebo comparator | Normal saline will be provided on a drip infusion to the selected group once coming off cardiopulmonary bypass following the Fontan operation. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest Tube Drainage
chest tube drainage until the day the chest tube is removed
Measured: From post operative day 0 through study completion, an average of 1 month
Secondary outcomes (1)
Length of Hospital Stay
Duration the patient remains in the hospital in days until the day of discharge home
Measured: From the day of the surgery (post operative day 0) through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamie Penk, MD, Principal investigator, Advocate Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975999
- Sponsor's protocol ID
- HRP-530
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2016
- Last updated
- 24 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Vasopressin Following the Fontan Operation: Both Pilot and Multicenter Studies
- ClinicalTrials.gov ID
- NCT02975999
- Acronym / sponsor ID
- HRP-530
- Conditions
- Pleural Effusion, Single-ventricle
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Posted 9 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to prepare for a larger study to determine whether Vasopressin following the Fontan operation will decrease chest tube output and duration.
Detailed description
A pilot randomized, double blinded clinical trial to evaluate the use of vasopressin following the Fontan operation.
Phase one of the study will be a single center pilot study and will be conducted at Advocate Children's Hospital, Oak Lawn IL. This will be a randomized and double blinded. Ten patients will be enrolled with five patients as control group and five receiving Vasopressin. Vasopressin levels will be obtained just prior to initiation of Vasopressin and 48 hours later in the pilot study. Safety and effect size will be evaluated after this pilot study.
Drug administration protocol:
Vasopressin at a dose of 0.4 mU/kg/min will be started on subjects in the study group while coming off cardiopulmonary bypass. The dose of Vasopressin will not be titrated. Study drug drip will infuse for 48 hours after which will be discontinued.
The placebo group will be receiving normal saline at the same rate of the vasopressin group. The treating physician will be blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vasopressin | Experimental | Drug: VasopressinVasopressin at 0.4mU/kg/min |
| Normal saline | Placebo comparator | Drug: Normal SalineNormal saline will be provided on a drip infusion to the selected group once coming off cardiopulmonary bypass following the Fontan operation. |
Who may qualify
- Ages
- 18 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Subjects between 1.5-7 years old undergoing Fontan operation.
Key exclusion criteria (4 listed)
- Patients with a planned fenestrated Fontan.
- Patients undergoing revision surgery for failing Fontan.
- Evidence of renal insufficiency prior to surgery defined by creatinine >1 mg/dl.
- Planned arch reconstruction at the time of the Fontan procedure
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 |
|---|---|---|
| VasopressinAlso: Vasostrict, arginineVasopressin at dose of 0.4mU/kg/min will be started on the assigned group once coming off cardiopulmonary bypass following the Fontan operation. | Drug | Vasopressin |
| Normal SalineAlso: PlaceboNormal saline at starting dose of 0.4mU/kg/min will be started on the assigned group once coming off cardiopulmonary bypass following the Fontan operation. | Drug | Normal saline |
Primary outcome
Chest Tube Drainage
Time frame: From post operative day 0 through study completion, an average of 1 month
chest tube drainage until the day the chest tube is removed
1 secondary outcome
Length of Hospital Stay
Time frame: From the day of the surgery (post operative day 0) through study completion, an average of 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jamie Penk, MD principal investigator
Advocate Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vasopressin and Normal Saline in people with Pleural Effusion and Single-ventricle, run by Wake Forest University Health Sciences at 1 site 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 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Chest Tube Drainage (time frame: From post operative day 0 through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2024.