N/A
N=14
Splanchnic Nerve Anesthesia in Heart Failure
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02669407 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Central Venous Pressure — 18.73; 14.91 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- splanchnic nerve anesthesia with a local anesthetic (Procedure); regional nerve block with a local anesthetic (Lidocaine) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Central Venous Pressure |
18.73; 14.91 | — |
| PRIMARY Pulmonary Arterial Mean Pressure |
45.45; 37.64 | <0.001 sig |
| PRIMARY Pulmonary Capillary Wedge Pressure |
30; 22 | 0.001 sig |
| SECONDARY Cardiac Index |
2.17; 2.59 | 0.007 sig |
| SECONDARY Ejection Fraction (LVEF) |
18.27; 19.4 | — |
| SECONDARY Pulmonary Artery Systolic Pressure |
65.18; 53.91 | — |
| SECONDARY Right Ventricular Diameter |
— | — |
| SECONDARY Left Ventricular Diameter |
6.2; 6.1; 5.4; 5.4 | 0.237 |
| SECONDARY N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Level |
4,297; 2,936 | 0.175 |
| SECONDARY Urine Output Measured in ml Over 3 Hours |
138.09; 258.64 | — |
| SECONDARY Change in Blood Urea Nitrogen (BUN) |
61; 53 | 0.061 |
| SECONDARY Change in Creatinine Level |
2.1; 1.9 | 0.787 |
| SECONDARY Dyspnea as Measured on Likert Scale |
2; 1; 4; 4; 0; 0 | — |
| SECONDARY Change in Clinical Symptoms, as Measured by 6 Minute Walk Test |
8.7; 24.7 | 0.606 |
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.
Eligibility Criteria
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 180 mmHg
- Restrictive or constrictive cardiomyopathy
- Chronic kidney disease stage 3 or higher due to primary renal pathology
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT02669407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.