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

October 10, 2017 updated by: Xiaotong Hou, Beijing Anzhen Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:
        • Principal Investigator:
          • Hong Wang, PhD., MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: 30 days
All-cause mortality
30 days
Rate of new arrhythmias
Time Frame: 30 days
Rate of new arrhythmias after cardiac surgery
30 days
Hormone levels
Time Frame: 30 days
Serum hormone levels after cardiac surgery, including vasopressin, catecholamine, corticosteroid and corticotropin-releasing hormone
30 days
Rate of ECMO or LVAD support
Time Frame: 30 days
Receiving extracorporeal membrane oxygenation (ECMO) or left ventricle assist device (LVAD) support
30 days
Duration on ventilator support
Time Frame: 30 days
Duration on ventilator support after cardiac surgery
30 days
ICU length of stay
Time Frame: 30 days
ICU length of stay
30 days
Hospital length of stay after cardiac surgery
Time Frame: 30 days
Hospital length of stay after cardiac surgery
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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