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Small Doses of Pituitrin Versus Norepinephrine for the Management of Vasoplegic Syndrome in Patients After Cardiac Surgery

NCT ID: NCT03106831

Last Updated: 2017-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-10

Study Completion Date

2019-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Vasoplegic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Pituitrin arm

To begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg.

Group Type EXPERIMENTAL

Pituitrin infusion

Intervention Type DRUG

To begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg.

Norepinephrine arm

To begin with 0.04 μg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg.

Group Type EXPERIMENTAL

Norepinephrine infusion

Intervention Type DRUG

To begin with 0.04 μg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg.

Interventions

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Pituitrin infusion

To begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg.

Intervention Type DRUG

Norepinephrine infusion

To begin with 0.04 μg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

1. Age \< 18 and \> 75 years.
2. Received renal replacement therapy before cardiac surgery.
3. Diagnosed as endocrine disease before cardiac surgery.
4. Diagnosed as sever peripheral vascular disease before cardiac surgery.
5. Extracorporeal membrane oxygenation support before admission.
6. To receive heart transplantation.
7. Infection on admission.
8. Pregnant or maternal patients.
9. Refusal of consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiaotong Hou

Director of Center for Cardiac Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hong Wang, PhD., MD.

Role: CONTACT

Phone: 86 15010516438

Email: [email protected]

Facility Contacts

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Hong Wang, PhD., MD.

Role: primary

Other Identifiers

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PX2016007

Identifier Type: -

Identifier Source: org_study_id