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

Not Applicable

• Conditions: Postoperative Vasoplegic Syndrome
• Interventions: Drug: Norepinephrine infusion; Drug: Pituitrin infusion

• Registration Number: NCT03106831
• Lead Sponsor: Beijing Anzhen Hospital

Brief 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). 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

Not available

Study Timeline

• Study First Submitted: 2017-03-31
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-10
• Status Verified: 2017-10
• Study Start: 2017-10-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-11
• Primary Completion: 2018-12-31
• Study Completion: 2019-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Norepinephrine arm	Norepinephrine infusion	To begin with 0.04 μg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg.
Pituitrin arm	Pituitrin infusion	To begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg.

Primary Outcome Measures

Name	Time	Method
Rate of in-hospital acute renal injury	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).

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality	30 days	All-cause mortality
Rate of new arrhythmias	30 days	Rate of new arrhythmias after cardiac surgery
Hormone levels	30 days	Serum hormone levels after cardiac surgery, including vasopressin, catecholamine, corticosteroid and corticotropin-releasing hormone
Rate of ECMO or LVAD support	30 days	Receiving extracorporeal membrane oxygenation (ECMO) or left ventricle assist device (LVAD) support
Duration on ventilator support	30 days	Duration on ventilator support after cardiac surgery
ICU length of stay	30 days	ICU length of stay
Hospital length of stay after cardiac surgery	30 days	Hospital length of stay after cardiac surgery

Trial Locations

Locations (1)

Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China