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

Primary Purpose

Postoperative Vasoplegic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pituitrin infusion
Norepinephrine infusion
Sponsored by
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Vasoplegic Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pituitrin arm

Norepinephrine arm

Arm Description

To begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg.

To begin with 0.04 μg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
March 31, 2017
Last Updated
October 10, 2017
Sponsor
Beijing Anzhen Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03106831
Brief Title
Small Doses of Pituitrin Versus Norepinephrine for the Management of Vasoplegic Syndrome in Patients After Cardiac Surgery
Official Title
Small Doses of Pituitrin Versus Norepinephrine for the Management of Vasoplegic Syndrome in Patients After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
April 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Vasoplegic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pituitrin arm
Arm Type
Experimental
Arm Description
To begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg.
Arm Title
Norepinephrine arm
Arm Type
Experimental
Arm Description
To begin with 0.04 μg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg.
Intervention Type
Drug
Intervention Name(s)
Pituitrin infusion
Intervention Description
To begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg.
Intervention Type
Drug
Intervention Name(s)
Norepinephrine infusion
Intervention Description
To begin with 0.04 μg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg.
Primary Outcome Measure Information:
Title
Rate of in-hospital acute renal injury
Description
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).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
In-hospital mortality
Description
All-cause mortality
Time Frame
30 days
Title
Rate of new arrhythmias
Description
Rate of new arrhythmias after cardiac surgery
Time Frame
30 days
Title
Hormone levels
Description
Serum hormone levels after cardiac surgery, including vasopressin, catecholamine, corticosteroid and corticotropin-releasing hormone
Time Frame
30 days
Title
Rate of ECMO or LVAD support
Description
Receiving extracorporeal membrane oxygenation (ECMO) or left ventricle assist device (LVAD) support
Time Frame
30 days
Title
Duration on ventilator support
Description
Duration on ventilator support after cardiac surgery
Time Frame
30 days
Title
ICU length of stay
Description
ICU length of stay
Time Frame
30 days
Title
Hospital length of stay after cardiac surgery
Description
Hospital length of stay after cardiac surgery
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Wang, PhD., MD.
Phone
86 15010516438
Email
914286855@qq.com
Facility Information:
Facility Name
Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Wang, PhD., MD.
Phone
86 15010516438
Email
914286855@qq.com
First Name & Middle Initial & Last Name & Degree
Hong Wang, PhD., MD.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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