Heart Rate Variability (HRV) to Evaluate Surgical Risk on Patients on Beta Blockers

This study has been withdrawn prior to enrollment.

(no patients were enrolled. Study was closed prior to study start.)

Sponsor:

Information provided by:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT01330654

First received: April 5, 2011

Last updated: June 25, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 5, 2011

Last Updated Date

June 25, 2012

Start Date ^ICMJE

March 2011

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Heart Rate Variability [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01330654 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Heart Rate Variability (HRV) to Evaluate Surgical Risk on Patients on Beta Blockers

Official Title ^ICMJE

Using Heart Rate Variability to Analyze the Effect of Beta Blockers on Intermediate Risk Patients Undergoing Laparoscopic Surgical Procedures

Brief Summary

Beta blockers have been shown to decrease the risk of intraoperative cardiac events in patients at high cardiac risk. However, they have also been associated with side effects (for instance, stroke.) The role of beta blockers in patients at intermediate cardiac risk undergoing surgery is controversial. Heart rate variability is a way of evaluating the cardiac function of a patient. Decreased heart rate variability is associated with early cardiac death in patients with congestive heart failure (CHF) and after a heart attack. It has been shown to transiently decrease in patients in hemorrhagic shock after trauma and returns to normal after resuscitation in trauma and burn patients. The investigators hypothesize that beta blockers will maintain pre operative heart rate variability in patients with intermediate risk of cardiac events during operative intervention with laparoscopic surgery.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)

Condition ^ICMJE

Cardiac Event Risk

Intervention ^ICMJE

Drug: metoprolol

50mg PO BID starting two weeks prior to surgery. Patients will be reevaluated one week prior to surgery. If their pulse is above 70, the dose will be increased to 100mg BID. If the HR is 50-70, the dose will not be changed. If the pulse is below 50, the dose will be decreased to 25mg. This dose will be continued for thirty days after operation.

Study Arm (s)

Active Comparator: Beta blocker
These patients will be randomized to receive a standard dose of metoprolol (50mg) starting two weeks prior to surgery

Intervention: Drug: metoprolol
No Intervention: Control
This arm will receive no additional treatment prior to surgery

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

March 2012

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

age 40-75 years old
intermediate risk of adverse cardiac events:
- renal insufficiency (CrCl < 60)
- diabetes mellitus
- two of the following:
  - age > 50
  - obesity
  - hypertension
  - hyperlipidemia
  - hypercholesterolemia
  - prior stroke
- undergoing an elective laparoscopic abdominal surgery less than three hours:
  - cholecystectomy
  - ventral hernia repair
  - umbilical hernia repair
  - gastric bypass or gastric banding

Exclusion Criteria:

currently taking a beta blocker
prior heart attack
rhythm other than sinus on ECG
contraindication to beta blockers:
- decompensated CHF
- severe valvular disease
- asthma
- COPD
- hypersensitivity to beta blockers
- heart rate < 60
currently taking a calcium channel blocker
urgent or emergent surgery

Gender

Both

Ages

40 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01330654

Other Study ID Numbers ^ICMJE

2010030

Has Data Monitoring Committee

Yes

Responsible Party

Jim Davis, Interim Program Director, Department of Surgery, UCSF Fresno

Study Sponsor ^ICMJE

University of California, San Francisco

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Ralph Wessel, MD

UCSF Fresno Department of Internal Medicine

Information Provided By

University of California, San Francisco

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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