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B-type Natriuretic Peptide Guided Therapy to Improve Clinical Outcomes for Patients Undergoing Non-cardiac Surgery (BETTER pilot)

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: NCT02679859
Recruitment Status : Unknown
Verified February 2016 by Bruce Biccard, University of Cape Town.
Recruitment status was:  Not yet recruiting
First Posted : February 10, 2016
Last Update Posted : February 11, 2016
Sponsor:
Collaborator:
University of Stellenbosch
Information provided by (Responsible Party):
Bruce Biccard, University of Cape Town

Brief Summary:
The primary hypothesis of the BETTER pilot trial is that B-type natriuretic peptide (BNP) directed medical therapy prior to noncardiac surgery will be associated with improved cardiovascular outcomes, when compared to standard of care.

Condition or disease Intervention/treatment Phase
Surgery Cardiovascular Complications Risk Assessment Other: BNP guided medical therapy optimisation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective, Multi-centre, Randomised Trial of B-type Natriuretic Peptide Guided Therapy to Improve Clinical Outcomes for Patients Undergoing Non-cardiac Surgery: the BETTER Surgery Pilot Trial
Study Start Date : July 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: B-type natriuretic guided medical therapy optimisation
B-type natriuretic guided medical therapy optimisation
Other: BNP guided medical therapy optimisation
No Intervention: Normal medical management



Primary Outcome Measures :
  1. A composite of 30 day mortality, nonfatal myocardial infarction, nonfatal cardiac arrest, congestive cardiac failure and re-operation. [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High risk elective preoperative noncardiac surgical patients who are referred to a preanaesthetic clinic for preoperative risk stratification.

Exclusion Criteria:

  1. Patient refusal to participate
  2. Where clinical opinion suggests that surgery cannot be postponed for at least 3 to 4 weeks to allow for clinical response to a change in medical therapy

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): NCT02679859


Contacts
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Contact: Bruce Biccard, MD, PhD bruce.biccard@uct.ac.za

Sponsors and Collaborators
University of KwaZulu
University of Stellenbosch
Investigators
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Principal Investigator: Bruce Biccard, MD, PhD University of Cape Town
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Responsible Party: Bruce Biccard, Head of Perioperative Medicine, University of Cape Town
ClinicalTrials.gov Identifier: NCT02679859    
Other Study ID Numbers: No Unique ID yet
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Bruce Biccard, University of Cape Town:
Natriuretic Peptide, Brain
Surgery