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RESIPI for Reducing Perioperative Major Adverse Cardiac Events (RESIPI)

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: NCT03208023
Recruitment Status : Terminated (Futility)
First Posted : July 5, 2017
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Cheetah Medical Inc.
Information provided by (Responsible Party):
Matthew McEvoy, Vanderbilt University Medical Center

Brief Summary:
This study aims to evaluate the effect of a novel hemodynamic management and monitoring strategy for reducing cardiac bio marker elevations and major adverse cardiac events.

Condition or disease Intervention/treatment Phase
Inotropy Fluid Management Cardiac Event Perioperative Cardiac Risk Vascular Resistance Hemodynamic Monitoring Hemodynamic Management Fluid Responsiveness Procedure: RESIPI Management Strategy Other: No intervention Not Applicable

Detailed Description:
Modest elevations in cardiac biomarkers in the immediate postoperative period are associated with significantly increased risk of morbidity and mortality. The RESIPI model of hemodynamic monitoring and management in the perioperative period takes into account the dynamic interplay of vascular resistance, inotropy, and fluid management. This study aims to evaluate the effect of a novel hemodynamic management and monitoring strategy for reducing cardiac bio marker elevations and major adverse cardiac events.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RESIPI for Reducing Perioperative Major Adverse Cardiac Events: A Phase II Prospective Randomized Controlled Trial
Actual Study Start Date : October 9, 2017
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : December 3, 2018

Arm Intervention/treatment
Active Comparator: Standard intraoperative care- no interventions
Standard intraoperative hemodynamic monitoring and treatment at Vanderbilt University Medical Center - No study interventions
Other: No intervention
No intervention

Experimental: RESIPI
Intraoperative implementation of RESIPI management strategy, a structured hemodynamic monitoring and treatment plan: RESIPI includes normalization of vascular resistance, correction of fluid responsiveness, and inotropy, and hemodynamic monitoring with the Starling SV (Cheetah Medical).
Procedure: RESIPI Management Strategy
a structured hemodynamic monitoring and treatment plan: RESIPI includes normalization of vascular resistance, correction of fluid responsiveness, and inotropy, and hemodynamic monitoring with the Starling SV (Cheetah Medical, Inc).




Primary Outcome Measures :
  1. B-typer Natriuretic Peptide (BNP) [ Time Frame: Post Op day 1 ]
    Change in BNP (>250 ng/ml)


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 30 days post op ]
  2. Major cardiac events [ Time Frame: 30 days post op ]
    Occurrence of major cardiac events (new arrhythmia, myocardial ischemia/infarction, congestive heart failure, or in-hospital cardiac arrest)

  3. Hospital length of stay [ Time Frame: Approximately 3-5 days ]
  4. Readmission rate (Emergency room or hospital) [ Time Frame: 30 days post operative ]
  5. Return to operating room [ Time Frame: 30 days post operative ]
  6. Total hospital cost [ Time Frame: 30 days post operative ]
  7. Occurrence of significant medical events [ Time Frame: 30 days post operative ]
    Occurrence of significant medical events (stroke, delirium, pneumonia, new oxygen requirement, need for re-intubation, acute kidney injury (KDIGO criteria), hyperglycemia (glucose >180)

  8. Days at home in first 30 days [ Time Frame: 30 days post operative ]


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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:

  • Revised Cardiac Risk Index greater than or equal to 1, history of diastolic dysfunction, or age greater than 55 years.
  • Surgery type: Major Abdominal Oncologic Surgery
  • Planned surgery length greater than or equal to 90 minutes with planned in-patient stay of at least 2 days

Exclusion Criteria:

  • Patients who are unstable by current American Heart Association/American College of Cardiology Clinical Practice Guidelines
  • Patients with Chronic Kidney Disease Stage IV or V
  • Urgent/emergent surgical interventions (e.g. Level 1 or 2 by VUMC VOR definitions)
  • No signs of ischemia, congestive heart failure, or volume overload: Creatinine Clearance greater than 30

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): NCT03208023


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
Cheetah Medical Inc.
Investigators
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Principal Investigator: Matthew D McEvoy, M.D. Vanderbilt University Medical Center
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Responsible Party: Matthew McEvoy, Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03208023    
Other Study ID Numbers: 170601
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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