Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533124
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Parameters of Cardiac Indices on the Ultrasonic Cardiac Output Monitor As Potential Indicators for Predicting the Achievement of Ultrafiltration Endpoint for Acute Heart Failure Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Parameters of Cardiac Indices on the Ultrasonic Cardiac Output Monitor As Potential Indicators for Predicting the Achievement of Ultrafiltration Endpoint for Acute Heart Failure Treatment
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background The feasibility of the ultrasonic cardiac output monitor USCOMapplying for determining ultrafiltration UF endpoints during acute heart failure AHF treatments was evaluated
Methods AHF patients were randomly assigned to UF U N20 and USCOMUF UU N20 groups The primary endpoint was differences in the hemodynamics of patients receiving UF alone or UFUSCOM A prediction model was established
Methods AHF patients were randomly assigned to UF U N20 and USCOMUF UU N20 groups The primary endpoint was differences in the hemodynamics of patients receiving UF alone or UFUSCOM A prediction model was established
Detailed Description:
This study was based on the ACCAHAHFSA guidelines for the management of heart failure and involved 40 patients diagnosed with acute decompensated heart failure ADHF from January 2022 to July 2023 Patients were randomly assigned to UF U N 20 and USCOM UF UU N 20 groups
The inclusion criteria were 1 Age 18 years 2 Male or non-pregnant female patients 3 Fluid overload manifested by at least two of the following a Pitting edema 2 of the lower extremities b Moist rales in the lungs c Jugular venous distention 10 cm d Pulmonary edema or pleural effusion on chest x-ray e Paroxysmal nocturnal dyspnea or two-pillow orthopnea f Congestive hepatomegaly or ascites e B-type natriuretic peptide BNP 400 pgmL
The exclusion criteria were 1 Hematocrit 45 2 Systolic blood pressure 90 mmHg and poor peripheral circulation 3 Contraindications to heparin anticoagulation4 Renal insufficiency with a Scr 30 mgdl or planned renal replacement therapies 5 Acute coronary syndromes 6 Life-threatening organ dysfunction caused by a dysregulated host response to infection 7 Active myocarditis 8 patients with heart failure attributed to restrictive or hypertrophic cardiomyopathy or uncorrected valvular stenotic disease 9 infection 10 malignancies 11 systemic immune disease 12 unwillingness to cooperate 13 withdrawal from the study or death The study adhered to the principles of the Declaration of Helsinki and the protocols were approved by the Institutional Review Board of our hospital 2019-072-01 Informed consent was obtained from all enrolled patients
Randomization
Patients were randomly assigned in a 11 ratio with one group receiving UF treatment alone and the other receiving UF treatment plus USCOM monitoring The allocation of study participants was processed through an interactive web response system with a non-stratified permutated block size Treating clinicians were unaware of patients group assignments there were a total of 40 patients
The operator steps of USCOM The operation of USCOM only requires placing the probe in the patients pulmonary artery window or aortic window for monitoring In pulmonary artery window monitoring the probe is positioned beside the right sternal border or upper abdomen to assess blood flow in the pulmonary artery thereby monitoring pulmonary circulation and right heart function For aortic window monitoring the probe is placed at the sternal notch or subclavian fossa same as the pulmonary artery window and measurements are taken through the aorta to assess systemic circulation primarily monitoring left ventricular output In this study only one skilled operator monitored all UU group patients
Assessments Patients were assessed at baseline and throughout the period of treatment The documented variables were medical history physical examination data echocardiography laboratory blood test monitoring continuous including the total UF volume body weight patient symptoms body position transcutaneous oxygen saturation degree of edema leg circumference abdominal circumference input-output balance and other variables for 7 days Adverse events AEs were assessed and documented by clinicians within 24 h
In the USCOM plus UF group cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patients height to estimate their cardiac output The monitored parameters included the SV index SVI SV variation SVV cardiac output CO cardiac index CI inotropy INO systemic vascular resistance index SVRI systemic vascular resistance SVR flow time corrected FTC and the velocity time integral VTI USCOM Thresholds of a 30 or 50 reduction in BNP relative to baseline were set as criteria for reaching the UF endpoint
Endpoints The primary endpoint was differences in the hemodynamics of patients in the UF alone and UF plus USCOM groups during UF monitored at 1 2 3 4 and 7 days The secondary endpoints were the identification of one or more indicators on the USCOM monitor that could predict the endpoint of UF Additionally the study assessed the economic benefits between the two groups
Statistical analysis All analyses and calculations of sample size were performed using SPSS Students t-test or analysis of variance ANOVA was used to look for differences in continuous regularly distributed variables and the Kruskal-Wallis test was employed to determine whether there were significant group differences The findings are presented as the mean SD A Mann-Whitney U test or Wilcoxon rank sum test was used for continuous variables that were not normally distributed and the results are reported as median Q1 Q3 To assess potential differences between categorical variables a χ² test or Fishers exact test was used for analysis P-values 005 were deemed to be significant
The inclusion criteria were 1 Age 18 years 2 Male or non-pregnant female patients 3 Fluid overload manifested by at least two of the following a Pitting edema 2 of the lower extremities b Moist rales in the lungs c Jugular venous distention 10 cm d Pulmonary edema or pleural effusion on chest x-ray e Paroxysmal nocturnal dyspnea or two-pillow orthopnea f Congestive hepatomegaly or ascites e B-type natriuretic peptide BNP 400 pgmL
The exclusion criteria were 1 Hematocrit 45 2 Systolic blood pressure 90 mmHg and poor peripheral circulation 3 Contraindications to heparin anticoagulation4 Renal insufficiency with a Scr 30 mgdl or planned renal replacement therapies 5 Acute coronary syndromes 6 Life-threatening organ dysfunction caused by a dysregulated host response to infection 7 Active myocarditis 8 patients with heart failure attributed to restrictive or hypertrophic cardiomyopathy or uncorrected valvular stenotic disease 9 infection 10 malignancies 11 systemic immune disease 12 unwillingness to cooperate 13 withdrawal from the study or death The study adhered to the principles of the Declaration of Helsinki and the protocols were approved by the Institutional Review Board of our hospital 2019-072-01 Informed consent was obtained from all enrolled patients
Randomization
Patients were randomly assigned in a 11 ratio with one group receiving UF treatment alone and the other receiving UF treatment plus USCOM monitoring The allocation of study participants was processed through an interactive web response system with a non-stratified permutated block size Treating clinicians were unaware of patients group assignments there were a total of 40 patients
The operator steps of USCOM The operation of USCOM only requires placing the probe in the patients pulmonary artery window or aortic window for monitoring In pulmonary artery window monitoring the probe is positioned beside the right sternal border or upper abdomen to assess blood flow in the pulmonary artery thereby monitoring pulmonary circulation and right heart function For aortic window monitoring the probe is placed at the sternal notch or subclavian fossa same as the pulmonary artery window and measurements are taken through the aorta to assess systemic circulation primarily monitoring left ventricular output In this study only one skilled operator monitored all UU group patients
Assessments Patients were assessed at baseline and throughout the period of treatment The documented variables were medical history physical examination data echocardiography laboratory blood test monitoring continuous including the total UF volume body weight patient symptoms body position transcutaneous oxygen saturation degree of edema leg circumference abdominal circumference input-output balance and other variables for 7 days Adverse events AEs were assessed and documented by clinicians within 24 h
In the USCOM plus UF group cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patients height to estimate their cardiac output The monitored parameters included the SV index SVI SV variation SVV cardiac output CO cardiac index CI inotropy INO systemic vascular resistance index SVRI systemic vascular resistance SVR flow time corrected FTC and the velocity time integral VTI USCOM Thresholds of a 30 or 50 reduction in BNP relative to baseline were set as criteria for reaching the UF endpoint
Endpoints The primary endpoint was differences in the hemodynamics of patients in the UF alone and UF plus USCOM groups during UF monitored at 1 2 3 4 and 7 days The secondary endpoints were the identification of one or more indicators on the USCOM monitor that could predict the endpoint of UF Additionally the study assessed the economic benefits between the two groups
Statistical analysis All analyses and calculations of sample size were performed using SPSS Students t-test or analysis of variance ANOVA was used to look for differences in continuous regularly distributed variables and the Kruskal-Wallis test was employed to determine whether there were significant group differences The findings are presented as the mean SD A Mann-Whitney U test or Wilcoxon rank sum test was used for continuous variables that were not normally distributed and the results are reported as median Q1 Q3 To assess potential differences between categorical variables a χ² test or Fishers exact test was used for analysis P-values 005 were deemed to be significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None