Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03106831
Recruitment Status : Unknown
Verified October 2017 by Xiaotong Hou, Beijing Anzhen Hospital.
Recruitment status was:  Recruiting
First Posted : April 10, 2017
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Xiaotong Hou, Beijing Anzhen Hospital

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.

Condition or disease Intervention/treatment Phase
Postoperative Vasoplegic Syndrome Drug: Pituitrin infusion Drug: Norepinephrine infusion Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Small Doses of Pituitrin Versus Norepinephrine for the Management of Vasoplegic Syndrome in Patients After Cardiac Surgery
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. In-hospital mortality [ Time Frame: 30 days ]
    All-cause mortality

  2. Rate of new arrhythmias [ Time Frame: 30 days ]
    Rate of new arrhythmias after cardiac surgery

  3. Hormone levels [ Time Frame: 30 days ]
    Serum hormone levels after cardiac surgery, including vasopressin, catecholamine, corticosteroid and corticotropin-releasing hormone

  4. Rate of ECMO or LVAD support [ Time Frame: 30 days ]
    Receiving extracorporeal membrane oxygenation (ECMO) or left ventricle assist device (LVAD) support

  5. Duration on ventilator support [ Time Frame: 30 days ]
    Duration on ventilator support after cardiac surgery

  6. ICU length of stay [ Time Frame: 30 days ]
    ICU length of stay

  7. Hospital length of stay after cardiac surgery [ Time Frame: 30 days ]
    Hospital length of stay after cardiac surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106831


Contacts
Layout table for location contacts
Contact: Hong Wang, PhD., MD. 86 15010516438 914286855@qq.com

Locations
Layout table for location information
China, Beijing
Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100029
Contact: Hong Wang, PhD., MD.    86 15010516438    914286855@qq.com   
Principal Investigator: Hong Wang, PhD., MD.         
Sponsors and Collaborators
Beijing Anzhen Hospital
Layout table for additonal information
Responsible Party: Xiaotong Hou, Director of Center for Cardiac Intensive Care, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT03106831    
Other Study ID Numbers: PX2016007
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Vasoplegia
Syndrome
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents