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

Capital Medical University

Status: Unknown

Conditions: Postoperative Vasoplegic Syndrome

Treatments: Drug: Norepinephrine infusion; Drug: Pituitrin infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03106831

PX2016007

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Pituitrin arm

Experimental group

Description:

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

Treatment:

Drug: Pituitrin infusion

Norepinephrine arm

Experimental group

Description:

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

Treatment:

Drug: Norepinephrine infusion