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

NCT06373575 | Enrolling By Invitation

• 1 other identifier: 2023-SR-891
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End-stage Renal Disease

Keywords

Kidney Failure, Chronic; heart failure

Outcome Measures

Primary Outcomes (2)

• Improvement in pulmonary congestion score

  within 72 hours following randomization

• Improvement in heart failure symptoms score

  within 72 hours following randomization

Secondary Outcomes (9)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

Fluid removal with the guidance of lung and inferior vena cava ultrasound before prolonged hemodialysis

Procedure: Lung and inferior vena cava ultrasound guidance

Control group

ACTIVE COMPARATOR

Fluid removal with the conventional protocol

Procedure: Conventional protocol guidance

Interventions

Lung and inferior vena cava ultrasound guidance PROCEDURE

The lung and inferior vena cava ultrasound will be utilized as guidance for the development of a dialysis prescription for prolonged hemodialysis.

Intervention group

Conventional protocol guidance PROCEDURE

Fluid removal using conventional protocol including blood pressure and physical examination

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients meet the diagnostic criteria for end-stage renal disease;
• 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;
• patients may require prolonged intermittent renal replacement therapy due to volume overload;
• patients ≥18 yo and ≤80 yo;
• either the patient or a family member signs the informed consent;
• patients will undergo at least two sessions of prolonged hemodialysis.

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Heart Failure

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Buyun Wu, PhD, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 18, 2024
• Study Start: May 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)