RESIPI for Reducing Perioperative Major Adverse Cardiac Events

Fluid Responsiveness Clinical Trial

— RESIPI  

Official title:

RESIPI for Reducing Perioperative Major Adverse Cardiac Events: A Phase II Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03208023
• Other study ID #: 170601
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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