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

NCT ID: NCT06373575

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-06-30

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.

Conditions

End-stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Lung and inferior vena cava ultrasound guidance

Intervention Type: PROCEDURE

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

Control group

Fluid removal with the conventional protocol

Group Type: ACTIVE_COMPARATOR

Conventional protocol guidance

Intervention Type: PROCEDURE

Fluid removal using conventional protocol including blood pressure and physical examination

Interventions

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.

Intervention Type: PROCEDURE

Conventional protocol guidance

Fluid removal using conventional protocol including blood pressure and physical examination

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Buyun Wu, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

2023-SR-891

Identifier Type: -

Identifier Source: org_study_id