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Splanchnic Nerve Anesthesia in Heart Failure

Duke University logo

Duke University

Status

Completed

Conditions

Heart Failure

Treatments

Drug: regional nerve block with a local anesthetic (Lidocaine)
Procedure: splanchnic nerve anesthesia with a local anesthetic

Study type

Interventional

Funder types

Other

Identifiers

NCT02669407
Pro00066528

Details and patient eligibility

About

Patients admitted for acute heart failure and undergoing right heart catheterization will be enrolled in this study. Subjects will undergo catheterization of the heart to obtain central cardiac pressure and other cardiac hemodynamic parameters. Subsequently, the subject will undergo a regional nerve block of the splanchnic nerves. Patients will remain in the catheterization lab for the duration of anesthetic block and will be continuously hemodynamically monitored.

This study will be a prospective, uncontrolled clinical trial. The study will not be controlled as invasive monitoring of hemodynamics will be performed, allowing clear demonstration of a cause-effect relationship. The goal of the study is to provide proof of concept.

Enrollment

14 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of heart failure (HF)
  • Prior admissions for decompensated HF
  • Symptomatic with dyspnea with clinical, radiographic or echocardiographic signs of fluid overload
  • On a stable HF drug regimen prior to admission
  • Anticipated hospital stay of at least 2 nights following catheterization procedure

Exclusion criteria

  • Ongoing treatment with oral anticoagulation other than aspirin
  • Immunosuppressive medications for solid organ transplant
  • Acute MI (STEMI or NSTEMI) within 7 days
  • Evidence of cardiogenic shock within 48 hours
  • Systolic blood pressure < 90 mmHg or >180 mmHg
  • Restrictive or constrictive cardiomyopathy
  • Chronic kidney disease stage 3 or higher due to primary renal pathology
  • Pregnancy

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

Regional nerve anesthesia
Experimental group
Description:
Regional nerve anesthesia of splanchnic nerve
Treatment:
Procedure: splanchnic nerve anesthesia with a local anesthetic
Drug: regional nerve block with a local anesthetic (Lidocaine)

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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