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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03208023
Other study ID # 170601
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 9, 2017
Est. completion date December 3, 2018

Study information

Verified date November 2022
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 155
Est. completion date December 3, 2018
Est. primary completion date November 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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).
Other:
No intervention
No intervention

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University Medical Center Cheetah Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary B-typer Natriuretic Peptide (BNP) Change in BNP (>250 ng/ml) Post Op day 1
Primary Troponin Change in troponin (>=0.04%) Post Op day 1
Secondary All-cause mortality 30 days post op
Secondary Major cardiac events Occurrence of major cardiac events (new arrhythmia, myocardial ischemia/infarction, congestive heart failure, or in-hospital cardiac arrest) 30 days post op
Secondary Hospital length of stay Approximately 3-5 days
Secondary Readmission rate (Emergency room or hospital) 30 days post operative
Secondary Return to operating room 30 days post operative
Secondary Total hospital cost 30 days post operative
Secondary Occurrence of significant medical events Occurrence of significant medical events (stroke, delirium, pneumonia, new oxygen requirement, need for re-intubation, acute kidney injury (KDIGO criteria), hyperglycemia (glucose >180) 30 days post operative
Secondary Days at home in first 30 days 30 days post operative
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