Splanchnic Nerve Anesthesia in Heart Failure

Not Applicable

Completed

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

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Regional nerve anesthesia	splanchnic nerve anesthesia with a local anesthetic	Regional nerve anesthesia of splanchnic nerve
Regional nerve anesthesia	regional nerve block with a local anesthetic (Lidocaine)	Regional nerve anesthesia of splanchnic nerve

Primary Outcome Measures

Name	Time	Method
Central Venous Pressure	Baseline, 90 minutes
Pulmonary Arterial Mean Pressure	baseline, 30 minutes
Pulmonary Capillary Wedge Pressure	baseline, 30 minutes

Secondary Outcome Measures

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