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

Postoperative Vasoplegic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03106831
• Other study ID #: PX2016007
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2017
• Last updated: October 10, 2017
• Start date: October 10, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: October 2017
• Source: Beijing Anzhen Hospital
• Contact: Hong Wang, PhD., MD.
• Phone: 86 15010516438
• Email: 914286855[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Vasoplegic Syndrome
• Syndrome
• Vasoplegia

Intervention

Drug:
• Pituitrin infusion
To begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg.
• Norepinephrine infusion
To begin with 0.04 µg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg.

Locations

Country	Name	City	State
China	Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of in-hospital acute renal injury	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).	30 days
Secondary	In-hospital mortality	All-cause mortality	30 days
Secondary	Rate of new arrhythmias	Rate of new arrhythmias after cardiac surgery	30 days
Secondary	Hormone levels	Serum hormone levels after cardiac surgery, including vasopressin, catecholamine, corticosteroid and corticotropin-releasing hormone	30 days
Secondary	Rate of ECMO or LVAD support	Receiving extracorporeal membrane oxygenation (ECMO) or left ventricle assist device (LVAD) support	30 days
Secondary	Duration on ventilator support	Duration on ventilator support after cardiac surgery	30 days
Secondary	ICU length of stay	ICU length of stay	30 days
Secondary	Hospital length of stay after cardiac surgery	Hospital length of stay after cardiac surgery	30 days