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

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 Overview

• Status: Unknown
• Conditions: Postoperative Vasoplegic Syndrome
• Intervention / Treatment: Drug: Pituitrin infusion; Drug: Norepinephrine infusion

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hong Wang, PhD., MD.; Phone Number: 86 15010516438; Email: 914286855@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
      • Contact: Hong Wang, PhD., MD.; Phone Number: 86 15010516438; Email: 914286855@qq.com
      • Principal Investigator: Hong Wang, PhD., MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pituitrin arm; To begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg.	Drug: Pituitrin infusion; To begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg.
Experimental: Norepinephrine arm; To begin with 0.04 μg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg.	Drug: Norepinephrine infusion; To begin with 0.04 μg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): April 30, 2019

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): October 11, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Disease; Syndrome; Vasoplegia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Norepinephrine
• Other Study ID Numbers: PX2016007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No