Splanchnic Nerve Anesthesia in Heart Failure

Splanchnic Nerve Block for Acute Heart Failure

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Procedure: splanchnic nerve anesthesia with a local anesthetic; Drug: regional nerve block with a local anesthetic (Lidocaine)

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regional nerve anesthesia; Regional nerve anesthesia of splanchnic nerve	Procedure: splanchnic nerve anesthesia with a local anesthetic; regional nerve block of the splanchnic nerve; Drug: regional nerve block with a local anesthetic (Lidocaine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Central Venous Pressure	Baseline, 90 minutes
Pulmonary Arterial Mean Pressure	baseline, 30 minutes
Pulmonary Capillary Wedge Pressure	baseline, 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac Index		baseline, 30 minutes
Ejection Fraction (LVEF)		Baseline, 90 minutes
Pulmonary Artery Systolic Pressure		Baseline, 30 minutes
Right Ventricular Diameter		Baseline, 30 mins
Left Ventricular Diameter		Baseline, 30 mins
N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Level	NT-proBNP level is elevated in heart failure and reflects its severity. A higher value indicates less stability.	Baseline; 90 minutes
Urine Output Measured in ml Over 3 Hours		Baseline, post-procedure (0-3 hours)
Change in Blood Urea Nitrogen (BUN)	BUN represents the major nitrogen excretion pathway and is used to evaluate renal function. Higher BUN levels indicate less stability.	Baseline; 90 minutes
Change in Creatinine Level	Creatinine measurements are used to evaluate renal function. Higher creatinine levels indicate less stability.	Baseline; 90 minutes
Dyspnea as Measured on Likert Scale	The scale ranges from -3 (markedly worse) to 3 (markedly improved). 0 = no change.	15, 30, 45, 60, 75, 90 minutes; 24 hours
Change in Clinical Symptoms, as Measured by 6 Minute Walk Test	The 6 Minute Walk Test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.	Baseline, 90 minutes, 24 hours

Collaborators and Investigators

• Sponsor: Duke University

Publications and helpful links

General Publications

• Fudim M, Patel MR, Boortz-Marx R, Borlaug BA, DeVore AD, Ganesh A, Green CL, Lopes RD, Mentz RJ, Patel CB, Rogers JG, Felker GM, Hernandez AF, Sunagawa K, Burkhoff D. Splanchnic Nerve Block Mediated Changes in Stressed Blood Volume in Heart Failure. JACC Heart Fail. 2021 Apr;9(4):293-300. doi: 10.1016/j.jchf.2020.12.006. Epub 2021 Mar 10.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: January 22, 2016
• First Submitted That Met QC Criteria: January 29, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Actual): December 6, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Membrane Transport Modulators; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics; Lidocaine; Anesthetics, Local
• Other Study ID Numbers: Pro00066528