Combined Spinal- Epidural Anesthesia in Patients With Dilated Cardiomyopathy

NCT03051529 | Completed DMC

• 1 other identifier: IRB00009900
• Study Type: observational
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was conducted on 24 patients who have ischemic dilated cardiomyopathy, underwent non cardiac surgery in the lower half of the body under the effect of combined spinal epidural anesthesia at Assiut university hospital. Intraoperative Hemodynamic monitoring including invasive blood pressure, heart rate, and CVP was established, in addition to pre and postoperative, 12 lead ECG, echocardiography, and venous sampling for Brain natriuretic peptide measurement were done . This study tried to assess the safety of this anesthetic technique on such group of cardiac patients along over the hospital stay period and up to 6 months postoperatively, in addition to the predictability of Brain natriuretic peptide as a cardiac biomarker regarding to the major adverse cardiac events and cardiac mortality for these group of patients .

Conditions

Cardiomyopathies

Outcome Measures

Primary Outcomes (1)

• early postoperative cardiac complications

  following up the patients for cardiac events such as arrhythmia , heart failure , new ischemic cardiac events

  7 days post operative

Secondary Outcomes (1)

• BNP level changes

  72 hours postoperative

Study Arms (1)

combined spinal epidural

24 patients with dilated cardiomyopathy undergoing vascular surgery in the lower half of the body under combined spinal epidural anesthesia will be enrolled in the study

Other: combined spinal epidural anesthesia

Interventions

combined spinal epidural anesthesia OTHER

After approval by local research ethics committee of the Faculty of Medicine, and informed written consent obtained from all patients, 24 patients having dilated cardiomyopathy, subjected to vascular surgery in the lower half of the body under CSEA

combined spinal epidural

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

24 patients having dilated cardiomyopathy, subjected to vascular surgery in the lower half of the body under combined spinal epidural anesthesia CSEA.

You may qualify if:

• patients Cardiomyopathy DCM underwent infra-inguinal vascular surgery under the effect of combined spinal epidural technique were included in a prospective trial single center observational study.

You may not qualify if:

• Patients with significant fluid and electrolyte imbalance, major arrhythmias or heart failure or unstable angina, systolic blood pressure at rest \< 100 mmHg, heart rate \< 50, serum creatinine \>2.0 mg /dl, and patients who required emergency surgery were excluded from the study.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and critical care Medicine

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: February 13, 2017
• Study Start: January 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 13, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share