NCT03106831

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

October 10, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

March 31, 2017

Last Update Submit

October 10, 2017

Conditions

Postoperative Vasoplegic Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • In-hospital mortality

    30 days

  • Rate of new arrhythmias

    30 days

  • Hormone levels

    30 days

  • Rate of ECMO or LVAD support

    30 days

  • Duration on ventilator support

    30 days

  • +2 more secondary outcomes

Study Arms (2)

Pituitrin arm

EXPERIMENTAL

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

Drug: Pituitrin infusion

Norepinephrine arm

EXPERIMENTAL

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

Drug: Norepinephrine infusion

Interventions

Pituitrin infusionDRUG

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

Pituitrin arm
Norepinephrine infusionDRUG

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

Norepinephrine arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Vasoplegia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Hong Wang, PhD., MD.

CONTACT

86 15010516438914286855@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Center for Cardiac Intensive Care

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 10, 2017

Study Start

October 10, 2017

Primary Completion

December 31, 2018

Study Completion

April 30, 2019

Last Updated

October 11, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)