Postoperative Vasoplegic SyndromeNCT03106831
Small Doses of Pituitrin Versus Norepinephrine for the Management of Vasoplegic Syndrome in Patients After Cardiac Surgery
A study testing Pituitrin infusion and Norepinephrine infusion in people with Postoperative Vasoplegic Syndrome, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
Vasoplegic syndrome is a common complication after cardiac surgery. Low dose vasopressin can up-regulate blood pressure and improve clinical outcomes compared with norepinephrine (mainly acute kidney injury Anesthesiology 2017; 126:85-93). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Vasoplegic Syndrome
- What is being tested?
- Pituitrin infusion and Norepinephrine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2017to 30 Apr 2019
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients diagnosed as vasoplegic syndrome(defined as mean arterial pressure less than 65 mmHg resistant to fluid challenge and cardiac index greater than 2.2 L/min · m2) within 24 hours after cardiac surgery.
Who cannot join
- Age < 18 and > 75 years.
- Received renal replacement therapy before cardiac surgery.
- Diagnosed as endocrine disease before cardiac surgery.
- Diagnosed as sever peripheral vascular disease before cardiac surgery.
- Extracorporeal membrane oxygenation support before admission.
- To receive heart transplantation.
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- Infection on admission.
- Pregnant or maternal patients.
- Refusal of consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Hong Wang, PhD., MD., 86 15010516438, 914286855@qq.com
Hong Wang, PhD., MD.
About this study
Vasoplegic syndrome is a common complication after cardiac surgery. Low dose vasopressin can up-regulate blood pressure and improve clinical outcomes compared with norepinephrine (mainly acute kidney injury Anesthesiology 2017; 126:85-93). Pituitrin is used as a substitute for vasopressin in our center, which contains both vasopressin and oxytocin. Oxytocin may alleviate inflammatory process-associated kidney injury (Peptides 2006;27:2249-57). Therefore, the investigators hypothesize Pituitrin may be preferable to norepinephrine in the renal protection of patients with vasoplegic syndrome after cardiac surgery. Moreover, the serum levels of vasopressin, catecholamine, corticosteroid and corticotropin-releasing hormone will be measured.
- Conditions
- Postoperative Vasoplegic Syndrome
- Being tested
- Pituitrin infusion, Norepinephrine infusion
- Medical subject headings
- Vasoplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pituitrin infusionDrug
To begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg.
Norepinephrine infusionDrug
To begin with 0.04 μg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Pituitrin arm | Experimental | To begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg. Receives: Drug: Pituitrin infusion |
| Norepinephrine arm | Experimental | To begin with 0.04 μg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg. Receives: Drug: Norepinephrine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of in-hospital acute renal injury
Acute renal injury (AKI) is defined as any of the following: (1) increase in serum creatinine (SCr) by ≥ 26.5lmol/l in 48 hours; (2) increase in SCr to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or (3) urine output < 0.5 ml/kg/h for 6 hours (urine output is only assessed when the CRRT machine is absent or with a fluid removal rate of 0 ml/h).
Measured: 30 days
Secondary outcomes (7)
In-hospital mortality
All-cause mortality
Measured: 30 days
Rate of new arrhythmias
Rate of new arrhythmias after cardiac surgery
Measured: 30 days
Hormone levels
Serum hormone levels after cardiac surgery, including vasopressin, catecholamine, corticosteroid and corticotropin-releasing hormone
Measured: 30 days
Rate of ECMO or LVAD support
Receiving extracorporeal membrane oxygenation (ECMO) or left ventricle assist device (LVAD) support
Measured: 30 days
Duration on ventilator support
Duration on ventilator support after cardiac surgery
Measured: 30 days
ICU length of stay
ICU length of stay
Measured: 30 days
Hospital length of stay after cardiac surgery
Hospital length of stay after cardiac surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start10 Oct 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Vasoplegic SyndromeStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaotong Hou, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106831
- Sponsor's protocol ID
- PX2016007
- Status last verified
- Oct 2017
- First submitted
- 31 Mar 2017
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Doses of Pituitrin Versus Norepinephrine for the Management of Vasoplegic Syndrome in Patients After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03106831
- Acronym / sponsor ID
- PX2016007
- Conditions
- Postoperative Vasoplegic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 10 Apr 2017 (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.
Vasoplegic syndrome is a common complication after cardiac surgery. Low dose vasopressin can up-regulate blood pressure and improve clinical outcomes compared with norepinephrine (mainly acute kidney injury Anesthesiology 2017; 126:85-93). Pituitrin is used as a substitute for vasopressin in our center, which contains both vasopressin and oxytocin. Oxytocin may alleviate inflammatory process-associated kidney injury (Peptides 2006;27:2249-57). Therefore, the investigators hypothesize Pituitrin may be preferable to norepinephrine in the renal protection of patients with vasoplegic syndrome after cardiac surgery. Moreover, the serum levels of vasopressin, catecholamine, corticosteroid and corticotropin-releasing hormone will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pituitrin arm | Experimental | Drug: Pituitrin infusionTo begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg. |
| Norepinephrine arm | Experimental | Drug: Norepinephrine infusionTo begin with 0.04 μg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients diagnosed as vasoplegic syndrome(defined as mean arterial pressure less than 65 mmHg resistant to fluid challenge and cardiac index greater than 2.2 L/min · m2) within 24 hours after cardiac surgery.
Key exclusion criteria (9 listed)
- Age < 18 and > 75 years.
- Received renal replacement therapy before cardiac surgery.
- Diagnosed as endocrine disease before cardiac surgery.
- Diagnosed as sever peripheral vascular disease before cardiac surgery.
- Extracorporeal membrane oxygenation support before admission.
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 |
|---|---|---|
| Pituitrin infusionTo begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg. | Drug | Pituitrin arm |
| Norepinephrine infusionTo begin with 0.04 μg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg. | Drug | Norepinephrine arm |
Primary outcome
Rate of in-hospital acute renal injury
Time frame: 30 days
Acute renal injury (AKI) is defined as any of the following: (1) increase in serum creatinine (SCr) by ≥ 26.5lmol/l in 48 hours; (2) increase in SCr to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or (3) urine output < 0.5 ml/kg/h for 6 hours (urine output is only assessed when the CRRT machine is absent or with a fluid removal rate of 0 ml/h).
7 secondary outcomes
In-hospital mortality
Time frame: 30 days
Rate of new arrhythmias
Time frame: 30 days
Hormone levels
Time frame: 30 days
Rate of ECMO or LVAD support
Time frame: 30 days
Duration on ventilator support
Time frame: 30 days
ICU length of stay
Time frame: 30 days
Hospital length of stay after cardiac surgery
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- 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 study testing Pituitrin infusion and Norepinephrine infusion in people with Postoperative Vasoplegic Syndrome, run by Beijing Anzhen Hospital at 1 site in China.
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 9 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 11 Oct 2017. 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 China. 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.
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 Hong Wang, PhD., MD. (86 15010516438, 914286855@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of in-hospital acute renal injury (time frame: 30 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 11 Oct 2017.