Splanchnic Nerve Anesthesia in Heart Failure

Heart Failure Clinical Trial

Official title:

Splanchnic Nerve Block for Acute Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02669407
• Other study ID #: Pro00066528
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: October 2018

Study information

• Verified date: May 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

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:

• 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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• splanchnic nerve anesthesia with a local anesthetic
regional nerve block of the splanchnic nerve

Drug:
• regional nerve block with a local anesthetic (Lidocaine)

Locations

Country	Name	City	State
United States	Duke	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Venous Pressure		Baseline, 90 minutes
Primary	Pulmonary Arterial Mean Pressure		baseline, 30 minutes
Primary	Pulmonary Capillary Wedge Pressure		baseline, 30 minutes
Secondary	Cardiac Index		baseline, 30 minutes
Secondary	Ejection Fraction (LVEF)		Baseline, 90 minutes
Secondary	Pulmonary Artery Systolic Pressure		Baseline, 30 minutes
Secondary	Right Ventricular Diameter		Baseline, 30 mins
Secondary	Left Ventricular Diameter		Baseline, 30 mins
Secondary	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
Secondary	Urine Output Measured in ml Over 3 Hours		Baseline, post-procedure (0-3 hours)
Secondary	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
Secondary	Change in Creatinine Level	Creatinine measurements are used to evaluate renal function. Higher creatinine levels indicate less stability.	Baseline; 90 minutes
Secondary	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
Secondary	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