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Low Dose Corticosteroid Infusion in Vasoplegia After Cardiac Surgery (CORTIVAS-CS) (CORTIVAS-CS)

Primary Purpose

Vasoplegia, Cardiac Surgery

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
hydrocortisone sodium succinate
Saline
Sponsored by
Instituto do Coracao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasoplegia focused on measuring vasoplegia, cardiac surgery, steroids

Eligibility Criteria

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

Inclusion Criteria:

  • Cardiac surgery with cardiopulmonary bypass
  • Norephinerine treatment in ICU with dose great or equal than 0,1 mcg/kg/min to maintain or restore a MAP over 70 mmHg for at least 30 minutes within 24 hours after surgery

Exclusion Criteria:

  • Preoperative vasopressor use (within 72 hours prior to surgery)
  • Preoperative steroids use (within 7 days prior to surgery)
  • Presence of ventricular assist device other than intraaortic ballon pump
  • Transplant procedures
  • Emergency procedures
  • Aortic repairs
  • Congenital procedures
  • Endocarditis
  • Bacterial or fungal infection in the preceding 30 days
  • Active neoplasia
  • Pregnancy
  • Recent history of gastrointestinal bleeding
  • Allergy or intolerance to steroids
  • Participation in other study

Sites / Locations

  • Incor - Heart Institute - University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Steroid

Control

Arm Description

Patients assigned for steroid group will receive 200 mg of hydrocortisone diluted in 120 mL of saline at an infusion rate of 5mL/hr for 3 days or shock reversal, defined by systolic arterial pressure > 90 mmHg for 12 hours after vasopressor weaning without fluid expansion.

Patients assigned for control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal, defined by systolic arterial pressure > 90 mmHg for 12 hours after vasopressor weaning without fluid expansion.

Outcomes

Primary Outcome Measures

Vasopressors-free days
Days free of vasopressors up to day 30

Secondary Outcome Measures

30 days mortallity
The number of deaths within 30 days of surgery
ICU length of stay
Duration in days from the date of the ICU admission to the date of ICU discharge
Infection complication
Rate of new infection or septic shock within 30 days after randomization
Acute myocardial infarction
We will compare the incidence of acute myocardial infarction between groups within 30 days after randomization
Atrial fibrillation
We will compare the incidence of atrial fibrillation between groups within 30 days after randomization

Full Information

First Posted
February 27, 2020
Last Updated
March 5, 2020
Sponsor
Instituto do Coracao
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1. Study Identification

Unique Protocol Identification Number
NCT04301479
Brief Title
Low Dose Corticosteroid Infusion in Vasoplegia After Cardiac Surgery (CORTIVAS-CS)
Acronym
CORTIVAS-CS
Official Title
Low Dose Corticosteroid Infusion in Vasoplegia After Cardiac Surgery (CORTIVAS-CS): a Prospective Randomized Double-blinded Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2020 (Anticipated)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto do Coracao

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Vasoplegia is an important determinant for adverse postoperative outcome and is observerd in 5% to 54% of patients undergoing cardiac surgery using cardiopulmonary bypass (CPB). Postoperative vasoplegia is defined as a state with low systemic vascular resistance despite a normal or high cardiac output, and the need for vasopressor therapy. Steroids attenuate the inflammatory response to cardiopulmonary bypass,but their effect on clinical outcomes is uncertain. This is a double-blinded, randomized, clinical trial designed to determine the efficacy of low dose corticosteroid infusion in vasopressor free-days in vasoplegia after cardiac surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasoplegia, Cardiac Surgery
Keywords
vasoplegia, cardiac surgery, steroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Steroid
Arm Type
Active Comparator
Arm Description
Patients assigned for steroid group will receive 200 mg of hydrocortisone diluted in 120 mL of saline at an infusion rate of 5mL/hr for 3 days or shock reversal, defined by systolic arterial pressure > 90 mmHg for 12 hours after vasopressor weaning without fluid expansion.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Patients assigned for control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal, defined by systolic arterial pressure > 90 mmHg for 12 hours after vasopressor weaning without fluid expansion.
Intervention Type
Drug
Intervention Name(s)
hydrocortisone sodium succinate
Intervention Description
Steroid group will receive 200 mg of hydrocortisone diluted in 120 mL of saline at an infusion rate of 5mL/hr for 3 days or shock reversal
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal
Primary Outcome Measure Information:
Title
Vasopressors-free days
Description
Days free of vasopressors up to day 30
Time Frame
30 days
Secondary Outcome Measure Information:
Title
30 days mortallity
Description
The number of deaths within 30 days of surgery
Time Frame
30 days
Title
ICU length of stay
Description
Duration in days from the date of the ICU admission to the date of ICU discharge
Time Frame
30 days
Title
Infection complication
Description
Rate of new infection or septic shock within 30 days after randomization
Time Frame
30 days
Title
Acute myocardial infarction
Description
We will compare the incidence of acute myocardial infarction between groups within 30 days after randomization
Time Frame
30 days
Title
Atrial fibrillation
Description
We will compare the incidence of atrial fibrillation between groups within 30 days after randomization
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Duration of mechanical ventilation
Description
Duration in hours from the intraoperative intubation to postoperative extubation
Time Frame
30 days
Title
Post-operative length of stay
Description
Post-operative LOS is the duration in days from the date of the end of surgery to the date of discharge from hospital.
Time Frame
30 days
Title
Mesenteric ischemia
Description
We will compare the atrial fibrillation between groups within 30 days after randomization
Time Frame
30 days
Title
Acute respiratory distress syndrome
Description
We will compare the incidence of acute respiratory distress syndrome between groups within 30 days after randomization
Time Frame
30 days
Title
Stroke
Description
We will compare the incidence of stroke between groups within 30 days after randomization
Time Frame
30 days
Title
Hyperglycemia
Description
Peak of capillary blood glucose glycemia up to 72 hours after the start the protocol solution
Time Frame
Up to 72 hours
Title
180 days mortallity
Description
The number of deaths within 180 days of surgery
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cardiac surgery with cardiopulmonary bypass Norephinerine treatment in ICU with dose great or equal than 0,1 mcg/kg/min to maintain or restore a MAP over 70 mmHg for at least 30 minutes within 24 hours after surgery Exclusion Criteria: Preoperative vasopressor use (within 72 hours prior to surgery) Preoperative steroids use (within 7 days prior to surgery) Presence of ventricular assist device other than intraaortic ballon pump Transplant procedures Emergency procedures Aortic repairs Congenital procedures Endocarditis Bacterial or fungal infection in the preceding 30 days Active neoplasia Pregnancy Recent history of gastrointestinal bleeding Allergy or intolerance to steroids Participation in other study
Facility Information:
Facility Name
Incor - Heart Institute - University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403000
Country
Brazil

12. IPD Sharing Statement

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Low Dose Corticosteroid Infusion in Vasoplegia After Cardiac Surgery (CORTIVAS-CS)

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