Small Doses of Pituitrin Versus Norepinephrine for the Management of Vasoplegic Syndrome in Patients After Cardiac Surgery
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Rate of in-hospital acute renal injury
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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.
- •Infection on admission.
- •Pregnant or maternal patients.
- •Refusal of consent
Arms & Interventions
Pituitrin arm
To begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg.
Intervention: Pituitrin infusion (Drug)
Norepinephrine arm
To begin with 0.04 μg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg.
Intervention: Norepinephrine infusion (Drug)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- In-hospital mortality(30 days)
- Rate of new arrhythmias(30 days)
- Hormone levels(30 days)
- Rate of ECMO or LVAD support(30 days)
- Duration on ventilator support(30 days)
- ICU length of stay(30 days)
- Hospital length of stay after cardiac surgery(30 days)
Investigators
Xiaotong Hou
Director of Center for Cardiac Intensive Care
Beijing Anzhen Hospital