Acute Kidney InjuryPhase 4NCT04602767
Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery
A Phase 4 study testing Vasopressin and Phenylephrine in people with Acute Kidney Injury, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This is a randomized, open label study to investigate vasopressin versus phenylephrine as a first line pressor in cardiac surgery. All patients >18 years of age presenting for coronary artery bypass graft (CABG), valve surgery, or combined CABG and valve surgery will be screened for inclusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Vasopressin and Phenylephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 1 Oct 2024
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Coronary artery bypass graft (CABG), valve, or combined CABG and valve surgery
Who cannot join
- Ejection fraction < 35%
- > moderate pulmonary hypertension
- > mild right ventricular dysfunction
- Radial arterial graft
- Circulatory arrest
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson Univesity
Philadelphia, Pennsylvania, 19146
Jordan Goldhammer, MD, jordan.goldhammer@jefferson.edu
About this study
This is a randomized, open label study to investigate vasopressin versus phenylephrine as a first line pressor in cardiac surgery. All patients >18 years of age presenting for coronary artery bypass graft (CABG), valve surgery, or combined CABG and valve surgery will be screened for inclusion. Patients with ejection fraction < 35%, > moderate pulmonary hypertension, > mild right ventricular dysfunction, a planned radial arterial graft, or circulatory arrest will be excluded. Patients will be randomized to receive either vasopressin or phenylephrine as the first line vasopressor during the perioperative period to maintain mean arterial blood pressure >65 mmhg. Primary outcome is acute kidney injury. Secondary outcomes are 30-day mortality, stroke, myocardial infarction, re-operation, sternal infection, atrial fibrillation, intensive care unit length of stay, and total vasopressor hours.
- Conditions
- Acute Kidney Injury
- Being tested
- Vasopressin, Phenylephrine
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasopressinDrug
Also called Pitressin
Vasopressin titrated 0.01 U/min up to 0.04 U/min for MAP < 65 mmHg
PhenylephrineDrug
Also called Neosynephrine
Phenylephrine titrated 0.25 mcg/kg/min up to 1.0 mcg/kg/min for MAP < 65 mmHg
| Study group | Role | What they receive |
|---|---|---|
| Vasopressin | Experimental | Low dose vasopressin as first line vasopressor in cardiac surgery. Receives: Drug: Vasopressin |
| Phenylephrine | Experimental | Low dose phenylephrine as first line vasopressor in cardiac surgery Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with acute kidney injury
KDIGO criteria
Measured: 5 Days
Secondary outcomes (6)
Number of patients with 30-Day Mortality
Number of patients with 30-Day Mortality
Measured: 30 Days
Number of patients with reoperation
Number of patients with reoperation
Measured: 5 Days
Number of patients with sternal Infection
Number of patients with sternal Infection
Measured: 5 Days
Number of patients with Atrial Fibrilation
Number of patients with Atrial Fibrilation
Measured: 5 Days
ICU Length of Stay
Total ICU Length of Stay
Measured: 5 Days
Total Vasopressor Hours
Total Vasopressor Hours
Measured: 5 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start15 Oct 2020
- Primary completion29 May 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson 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
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordan Goldhammer, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602767
- Sponsor's protocol ID
- 20D.847
- Status last verified
- Mar 2024
- First submitted
- 20 Oct 2020
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04602767
- Acronym / sponsor ID
- 20D.847
- Conditions
- Acute Kidney Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 29 May 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 26 Oct 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.
This is a randomized, open label study to investigate vasopressin versus phenylephrine as a first line pressor in cardiac surgery. All patients >18 years of age presenting for coronary artery bypass graft (CABG), valve surgery, or combined CABG and valve surgery will be screened for inclusion. Patients with ejection fraction < 35%, > moderate pulmonary hypertension, > mild right ventricular dysfunction, a planned radial arterial graft, or circulatory arrest will be excluded. Patients will be randomized to receive either vasopressin or phenylephrine as the first line vasopressor during the perioperative period to maintain mean arterial blood pressure >65 mmhg. Primary outcome is acute kidney injury. Secondary outcomes are 30-day mortality, stroke, myocardial infarction, re-operation, sternal infection, atrial fibrillation, intensive care unit length of stay, and total vasopressor hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vasopressin | Experimental | Drug: VasopressinLow dose vasopressin as first line vasopressor in cardiac surgery. |
| Phenylephrine | Experimental | Drug: PhenylephrineLow dose phenylephrine as first line vasopressor in cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years of age
- Coronary artery bypass graft (CABG), valve, or combined CABG and valve surgery
Key exclusion criteria (5 listed)
- Ejection fraction < 35%
- > moderate pulmonary hypertension
- > mild right ventricular dysfunction
- Radial arterial graft
- Circulatory arrest
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: PitressinVasopressin titrated 0.01 U/min up to 0.04 U/min for MAP < 65 mmHg | Drug | Vasopressin |
| PhenylephrineAlso: NeosynephrinePhenylephrine titrated 0.25 mcg/kg/min up to 1.0 mcg/kg/min for MAP < 65 mmHg | Drug | Phenylephrine |
Primary outcome
Number of patients with acute kidney injury
Time frame: 5 Days
KDIGO criteria
6 secondary outcomes
Number of patients with 30-Day Mortality
Time frame: 30 Days
Number of patients with reoperation
Time frame: 5 Days
Number of patients with sternal Infection
Time frame: 5 Days
Number of patients with Atrial Fibrilation
Time frame: 5 Days
ICU Length of Stay
Time frame: 5 Days
Total Vasopressor Hours
Time frame: 5 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vasopressin and Phenylephrine in people with Acute Kidney Injury, run by Thomas Jefferson University 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Mar 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. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenifer Lessin (215 955-5804, jennifer.lessin@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with acute kidney injury (time frame: 5 Days). 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 29 Mar 2024.