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

Not Applicable

• Conditions: End-stage Renal Disease
• Interventions: Procedure: Lung and inferior vena cava ultrasound guidance; Procedure: Conventional protocol guidance

• Registration Number: NCT06373575
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

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 Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-15
• Last Update Submitted: 2024-04-15
• Study First Posted: 2024-04-18
• Last Update Posted: 2024-04-18
• Study Start: 2024-05-01
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Lung and inferior vena cava ultrasound guidance	Fluid removal with the guidance of lung and inferior vena cava ultrasound before prolonged hemodialysis
Control group	Conventional protocol guidance	Fluid removal with the conventional protocol

Primary Outcome Measures

Name	Time	Method
Improvement in pulmonary congestion score	within 72 hours following randomization
Improvement in heart failure symptoms score	within 72 hours following randomization

Secondary Outcome Measures

Name	Time	Method
Total ultrafiltration volume	within 72 hours following randomization
The change of width of inferior vena cava	within 72 hours following randomization
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
Fluid balance (total outflow - total inflow)	within 72 hours following randomization
Lung B-line reduction	within 72 hours following randomization
Incidence of hypotension during prolonged hemodialysis	within 72 hours following randomization
Mean ultrafiltration rate 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

Trial Locations

Locations (1)

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China