Trial Outcomes & Findings for Splanchnic Nerve Anesthesia in Heart Failure (NCT NCT02669407)

NCT ID: NCT02669407

Last Updated: 2019-12-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: Baseline, 90 minutes
• Results posted on: 2019-12-06

Participant Flow

Recruited patients hospitalized for acute decompensated heart failure (ADHF) at Duke University Hospital between April 2017 and May 2018.

Participant milestones

Measure	Regional Nerve Anesthesia Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine)
Overall Study STARTED	14
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Regional Nerve Anesthesia Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine)
Overall Study Physician Decision	3

Baseline Characteristics

Splanchnic Nerve Anesthesia in Heart Failure

Baseline characteristics by cohort

Measure	Regional Nerve Anesthesia n=11 Participants Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine)
Age, Continuous	64 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants
Central Venous Pressure	18.73 mmHg STANDARD_DEVIATION 5.57 • n=5 Participants
Pulmonary Arterial Mean Pressure	45.45 mmHg STANDARD_DEVIATION 5.99 • n=5 Participants
Pulmonary Capillary Wedge Pressure	30 mmHg STANDARD_DEVIATION 7 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 90 minutes

Population: Participants who completed the study

Outcome measures

Measure	Regional Nerve Anesthesia n=11 Participants Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine)
Central Venous Pressure Baseline	18.73 mmHg Standard Deviation 5.57
Central Venous Pressure 90 minutes	14.91 mmHg Standard Deviation 5.24

PRIMARY outcome

Timeframe: baseline, 30 minutes

Population: Participants who completed the study.

Outcome measures

Measure	Regional Nerve Anesthesia n=11 Participants Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine)
Pulmonary Arterial Mean Pressure Baseline	45.45 mmHg Standard Deviation 5.99
Pulmonary Arterial Mean Pressure 30 minutes	37.64 mmHg Standard Deviation 7.03

PRIMARY outcome

Timeframe: baseline, 30 minutes

Population: Participants who completed the study.

Outcome measures

Measure	Regional Nerve Anesthesia n=11 Participants Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine)
Pulmonary Capillary Wedge Pressure Baseline	30 mmHg Standard Deviation 7
Pulmonary Capillary Wedge Pressure 30 minutes	22 mmHg Standard Deviation 7

SECONDARY outcome

Timeframe: baseline, 30 minutes

Population: Participants who completed the study.

Outcome measures

Measure	Regional Nerve Anesthesia n=11 Participants Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine)
Cardiac Index Baseline	2.17 L/min/m^2 Standard Deviation 0.74
Cardiac Index 30 minutes	2.59 L/min/m^2 Standard Deviation 0.65

SECONDARY outcome

Timeframe: Baseline, 90 minutes

Population: Participants who completed the study

Outcome measures

Measure	Regional Nerve Anesthesia n=11 Participants Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine)
Ejection Fraction (LVEF) Baseline	18.27 percentage of ejected blood per contract Standard Deviation 11.18
Ejection Fraction (LVEF) 90 minutes	19.4 percentage of ejected blood per contract Standard Deviation 10.32

SECONDARY outcome

Timeframe: Baseline, 30 minutes

Outcome measures

Measure	Regional Nerve Anesthesia n=11 Participants Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine)
Pulmonary Artery Systolic Pressure Baseline	65.18 mmHg Standard Deviation 9.95
Pulmonary Artery Systolic Pressure 30 minutes	53.91 mmHg Standard Deviation 12.47

SECONDARY outcome

Timeframe: Baseline, 30 mins

Population: Data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 30 mins

Population: Participants who completed the study

Outcome measures

Measure	Regional Nerve Anesthesia n=11 Participants Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine)
Left Ventricular Diameter Left ventricular end diastolic dimension; Baseline	6.2 cm Standard Deviation 1.0
Left Ventricular Diameter Left ventricular end diastolic dimension; 30 mins	6.1 cm Standard Deviation 0.9
Left Ventricular Diameter Left ventricular end systolic dimension; Baseline	5.4 cm Standard Deviation 1.3
Left Ventricular Diameter Left ventricular end systolic dimension; 30 mins	5.4 cm Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline; 90 minutes

Population: Participants who completed the study.

NT-proBNP level is elevated in heart failure and reflects its severity. A higher value indicates less stability.

Outcome measures

Measure	Regional Nerve Anesthesia n=11 Participants Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine)
N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Level Baseline	4,297 pg/dL
N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Level 90 minutes	2,936 pg/dL

SECONDARY outcome

Timeframe: Baseline, post-procedure (0-3 hours)

Population: Participants who completed the study.

Outcome measures

Measure	Regional Nerve Anesthesia n=11 Participants Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine)
Urine Output Measured in ml Over 3 Hours Baseline	138.09 ml over 3 hours Standard Deviation 92.22
Urine Output Measured in ml Over 3 Hours post-procedure 0-3 hours	258.64 ml over 3 hours Standard Deviation 199.22

SECONDARY outcome

Timeframe: Baseline; 90 minutes

Population: Participants who completed the study.

BUN represents the major nitrogen excretion pathway and is used to evaluate renal function. Higher BUN levels indicate less stability.

Outcome measures

Measure	Regional Nerve Anesthesia n=11 Participants Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine)
Change in Blood Urea Nitrogen (BUN) Baseline	61 mg/dL Interval 31.0 to 68.0
Change in Blood Urea Nitrogen (BUN) 90 minutes	53 mg/dL Interval 26.0 to 68.0

SECONDARY outcome

Timeframe: Baseline; 90 minutes

Population: Participants who completed the study.

Creatinine measurements are used to evaluate renal function. Higher creatinine levels indicate less stability.

Outcome measures

Measure	Regional Nerve Anesthesia n=11 Participants Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine)
Change in Creatinine Level Baseline	2.1 mg/dL Interval 1.5 to 2.6
Change in Creatinine Level 90 minutes	1.9 mg/dL Interval 1.4 to 2.7

SECONDARY outcome

Timeframe: 15, 30, 45, 60, 75, 90 minutes; 24 hours

Population: Participants who completed the study.

The scale ranges from -3 (markedly worse) to 3 (markedly improved). 0 = no change.

Outcome measures

Measure	Regional Nerve Anesthesia n=11 Participants Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine)
Dyspnea as Measured on Likert Scale 15 minutes · 3=Markedly improved	2 Participants
Dyspnea as Measured on Likert Scale 15 minutes · 2=Moderately Improved	1 Participants
Dyspnea as Measured on Likert Scale 15 minutes · 1=Minimally improved	4 Participants
Dyspnea as Measured on Likert Scale 15 minutes · 0=No change	4 Participants
Dyspnea as Measured on Likert Scale 15 minutes · -1=Minimally worse	0 Participants
Dyspnea as Measured on Likert Scale 15 minutes · -2=Moderately worse	0 Participants
Dyspnea as Measured on Likert Scale 15 minutes · -3=Markedly worse	0 Participants
Dyspnea as Measured on Likert Scale 30 minutes · 3=Markedly improved	0 Participants
Dyspnea as Measured on Likert Scale 30 minutes · 2=Moderately Improved	3 Participants
Dyspnea as Measured on Likert Scale 30 minutes · 1=Minimally improved	5 Participants
Dyspnea as Measured on Likert Scale 30 minutes · 0=No change	2 Participants
Dyspnea as Measured on Likert Scale 30 minutes · -1=Minimally worse	1 Participants
Dyspnea as Measured on Likert Scale 30 minutes · -2=Moderately worse	0 Participants
Dyspnea as Measured on Likert Scale 30 minutes · -3=Markedly worse	0 Participants
Dyspnea as Measured on Likert Scale 45 minutes · 3=Markedly improved	0 Participants
Dyspnea as Measured on Likert Scale 45 minutes · 2=Moderately Improved	3 Participants
Dyspnea as Measured on Likert Scale 45 minutes · 1=Minimally improved	7 Participants
Dyspnea as Measured on Likert Scale 45 minutes · 0=No change	1 Participants
Dyspnea as Measured on Likert Scale 45 minutes · -1=Minimally worse	0 Participants
Dyspnea as Measured on Likert Scale 45 minutes · -2=Moderately worse	0 Participants
Dyspnea as Measured on Likert Scale 45 minutes · -3=Markedly worse	0 Participants
Dyspnea as Measured on Likert Scale 60 minutes · 3=Markedly improved	0 Participants
Dyspnea as Measured on Likert Scale 60 minutes · 2=Moderately Improved	1 Participants
Dyspnea as Measured on Likert Scale 60 minutes · 1=Minimally improved	5 Participants
Dyspnea as Measured on Likert Scale 60 minutes · 0=No change	4 Participants
Dyspnea as Measured on Likert Scale 60 minutes · -1=Minimally worse	1 Participants
Dyspnea as Measured on Likert Scale 60 minutes · -2=Moderately worse	0 Participants
Dyspnea as Measured on Likert Scale 60 minutes · -3=Markedly worse	0 Participants
Dyspnea as Measured on Likert Scale 75 minutes · 3=Markedly improved	1 Participants
Dyspnea as Measured on Likert Scale 75 minutes · 2=Moderately Improved	2 Participants
Dyspnea as Measured on Likert Scale 75 minutes · 1=Minimally improved	3 Participants
Dyspnea as Measured on Likert Scale 75 minutes · 0=No change	5 Participants
Dyspnea as Measured on Likert Scale 75 minutes · -1=Minimally worse	0 Participants
Dyspnea as Measured on Likert Scale 75 minutes · -2=Moderately worse	0 Participants
Dyspnea as Measured on Likert Scale 75 minutes · -3=Markedly worse	0 Participants
Dyspnea as Measured on Likert Scale 90 minutes · 3=Markedly improved	3 Participants
Dyspnea as Measured on Likert Scale 90 minutes · 2=Moderately Improved	2 Participants
Dyspnea as Measured on Likert Scale 90 minutes · 1=Minimally improved	3 Participants
Dyspnea as Measured on Likert Scale 90 minutes · 0=No change	3 Participants
Dyspnea as Measured on Likert Scale 90 minutes · -1=Minimally worse	0 Participants
Dyspnea as Measured on Likert Scale 90 minutes · -2=Moderately worse	0 Participants
Dyspnea as Measured on Likert Scale 90 minutes · -3=Markedly worse	0 Participants
Dyspnea as Measured on Likert Scale 24 hours · 3=Markedly improved	3 Participants
Dyspnea as Measured on Likert Scale 24 hours · 2=Moderately Improved	2 Participants
Dyspnea as Measured on Likert Scale 24 hours · 1=Minimally improved	5 Participants
Dyspnea as Measured on Likert Scale 24 hours · 0=No change	0 Participants
Dyspnea as Measured on Likert Scale 24 hours · -1=Minimally worse	0 Participants
Dyspnea as Measured on Likert Scale 24 hours · -2=Moderately worse	0 Participants
Dyspnea as Measured on Likert Scale 24 hours · -3=Markedly worse	1 Participants

SECONDARY outcome

Timeframe: Baseline, 90 minutes, 24 hours

Population: Participants who completed the study.

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.

Outcome measures

Measure	Regional Nerve Anesthesia n=11 Participants Regional nerve anesthesia of splanchnic nerve splanchnic nerve anesthesia with a local anesthetic: regional nerve block of the splanchnic nerve regional nerve block with a local anesthetic (Lidocaine)
Change in Clinical Symptoms, as Measured by 6 Minute Walk Test Baseline, 90 minutes	8.7 meters Standard Deviation 51.6
Change in Clinical Symptoms, as Measured by 6 Minute Walk Test Baseline, 24 hours	24.7 meters Standard Deviation 31.2

Adverse Events

Regional Nerve Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marat Fudim, M.D.

Duke University

Phone: 919-684-8111

Email: marat.fudim@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place