RESIPI for Reducing Perioperative Major Adverse Cardiac Events

NCT03208023 | Terminated

• 1 other identifier: 170601
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Inotropy; Fluid Management; Cardiac Event; Perioperative Cardiac Risk; Vascular Resistance; Hemodynamic Monitoring; Hemodynamic Management; Fluid Responsiveness

Outcome Measures

Primary Outcomes (2)

• B-typer Natriuretic Peptide (BNP)

  Change in BNP (\>250 ng/ml)

  Post Op day 1

• Troponin

  Change in troponin (\>=0.04%)

  Post Op day 1

Secondary Outcomes (8)

• All-cause mortality

  30 days post op

• Major cardiac events

  30 days post op

• Hospital length of stay

  Approximately 3-5 days

• Readmission rate (Emergency room or hospital)

  30 days post operative

• Return to operating room

  30 days post operative

Study Arms (2)

Standard intraoperative care- no interventions

ACTIVE COMPARATOR

Standard intraoperative hemodynamic monitoring and treatment at Vanderbilt University Medical Center - No study interventions

Other: No intervention

RESIPI

EXPERIMENTAL

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

Interventions

RESIPI Management Strategy PROCEDURE

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).

RESIPI

No intervention OTHER

No intervention

Standard intraoperative care- no interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Cheetah Medical Inc.: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Matthew D McEvoy, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 5, 2017
• Study Start: October 9, 2017
• Primary Completion: November 1, 2018
• Study Completion: December 3, 2018
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)