Postoperative Vasoplegic Syndrome
Conditions
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.
Interventions
To begin with 0.04 μg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg.
DRUGPituitrin infusion
To begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg.
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| In-hospital mortality | 30 days | All-cause mortality |
| 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 |
| Duration on ventilator support | 30 days | Duration on ventilator support after cardiac surgery |
Countries
China
Contacts
Primary ContactHong Wang, PhD., MD.
Outcome results
None listed