NCT04301479

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.

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
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_3

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

February 27, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

February 27, 2020

Last Update Submit

March 5, 2020

Conditions

VasoplegiaCardiac Surgery

Keywords

vasoplegiacardiac surgerysteroids

Outcome Measures

Primary Outcomes (1)

  • Vasopressors-free days

    Days free of vasopressors up to day 30

    30 days

Secondary Outcomes (5)

  • 30 days mortallity

    30 days

  • ICU length of stay

    30 days

  • Infection complication

    30 days

  • Acute myocardial infarction

    30 days

  • Atrial fibrillation

    30 days

Other Outcomes (7)

  • Duration of mechanical ventilation

    30 days

  • Post-operative length of stay

    30 days

  • Mesenteric ischemia

    30 days

  • +4 more other outcomes

Study Arms (2)

Steroid

ACTIVE COMPARATOR

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.

Drug: hydrocortisone sodium succinate

Control

PLACEBO COMPARATOR

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.

Drug: Saline

Interventions

hydrocortisone sodium succinateDRUG

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

Steroid
SalineDRUG

Control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal

Control

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Incor - Heart Institute - University of Sao Paulo

São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Vasoplegia

Interventions

HydrocortisoneSodium Chloride

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-HydroxycorticosteroidsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology at University São Paulo Medical School

Study Record Dates

First Submitted

February 27, 2020

First Posted

March 10, 2020

Study Start

March 1, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

BR(1)