IVC and Lung Ultrasound B-lines Guided Decongestion in Critically Ill ESKD Patients With Heart Failure

Inferior Vena Cava and Lung Ultrasound B-lines Guided Decongestion in Critically Ill Kidney Failure Patients With Heart Failure: a Single-center, Prospective, Randomized Controlled Intervention Study

The objectives of this trial are to determine whether, in critically ill ESKD patients randomization to fluid removal guided by lung and inferior vena cava ultrasound, compared to standard care, leads to Improved pulmonary congestion (primary outcome); and safety (secondary outcome) in the short-term.

Study Overview

• Status: Enrolling by invitation
• Conditions: End-stage Renal Disease
• Intervention / Treatment: Procedure: Lung and inferior vena cava ultrasound guidance; Procedure: Conventional protocol guidance

Detailed Description

The point-of-care ultrasound was thought useful in the management of fluid in critically ill patients. At present, the role of the lung and inferior vena cava ultrasound is unclear in the management of decongestion of heart failure in kidney failure (KF) patients using prolonged hemodialysis. The investigators aim to explore the effect of pre-dialysis probing with the lung and inferior vena cava to guide fluid removal as compared with conventional protocols on the improvement of heart failure symptoms in patients with KF with heart failure under prolonged hemodialysis in the short-term.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. patients meet the diagnostic criteria for end-stage renal disease;
2. indications that the patient may be experiencing signs and/or symptoms of heart failure, and based on the serum N-terminal pro-brain natriuretic peptide level of greater than 11,215. 2 ng/L;
3. patients may require prolonged intermittent renal replacement therapy due to volume overload;
4. patients ≥18 yo and ≤80 yo;
5. either the patient or a family member signs the informed consent;
6. patients will undergo at least two sessions of prolonged hemodialysis.

Exclusion Criteria:

1. history of malignancy or psychiatric disease;
2. patients with a history of congenital heart disease or hypertrophic cardiomyopathy;
3. coagulation abnormalities, intracranial, visceral or gastrointestinal bleeding in the past 3 months, or contraindications to heparin anticoagulation;
4. The duration of prolonged hemodialysis <8 hours;
5. Ultrasound unable to monitor the inferior vena cava, or can't access the date;
6. Pregnancy;
7. Patients with severe respiratory failure;
8. Patients with combined severe infections, such as patients with sepsis;
9. Presence of pre-dialysis hypotension: systolic blood pressure <90 mmHg;
10. other conditions deemed ineligible by physicians.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Fluid removal with the guidance of lung and inferior vena cava ultrasound before prolonged hemodialysis	Procedure: Lung and inferior vena cava ultrasound guidance; The lung and inferior vena cava ultrasound will be utilized as guidance for the development of a dialysis prescription for prolonged hemodialysis.
Active Comparator: Control group; Fluid removal with the conventional protocol	Procedure: Conventional protocol guidance; Fluid removal using conventional protocol including blood pressure and physical examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in pulmonary congestion score	within 72 hours following randomization
Improvement in heart failure symptoms score	within 72 hours following randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
Total ultrafiltration volume	within 72 hours following randomization
Mean ultrafiltration rate during prolonged hemodialysis	within 72 hours following randomization
Fluid balance (total outflow - total inflow)	within 72 hours following randomization
Lung B-line reduction	within 72 hours following randomization
The change of width of inferior vena cava	within 72 hours following randomization
Incidence of hypotension during prolonged hemodialysis	within 72 hours following randomization
Blood pressure variability during the prolonged hemodialysis	within 72 hours following randomization
In-hospital mortality	From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 100 days
Length of hospital stay	From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 100 days

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Principal Investigator: Buyun Wu, PhD, MD, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: heart failure; Kidney Failure, Chronic
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Kidney Failure, Chronic
• Other Study ID Numbers: 2023-SR-891

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No