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

Nanjing Medical University

Status: Invitation-only

Conditions: End-stage Renal Disease

Treatments: Procedure: Lung and inferior vena cava ultrasound guidance; Procedure: Conventional protocol guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT06373575

2023-SR-891

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Procedure: Lung and inferior vena cava ultrasound guidance

Control group

Active Comparator group

Description:

Fluid removal with the conventional protocol

Treatment:

Procedure: Conventional protocol guidance