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

End-stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06373575
• Other study ID #: 2023-SR-891
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: June 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• End-stage Renal Disease
• Heart Failure
• Kidney Failure, Chronic

Intervention

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.
• Conventional protocol guidance
Fluid removal using conventional protocol including blood pressure and physical examination

Locations

Country	Name	City	State
China	Jiangsu Province Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in pulmonary congestion score		within 72 hours following randomization
Primary	Improvement in heart failure symptoms score		within 72 hours following randomization
Secondary	Total ultrafiltration volume		within 72 hours following randomization
Secondary	Mean ultrafiltration rate during prolonged hemodialysis		within 72 hours following randomization
Secondary	Fluid balance (total outflow - total inflow)		within 72 hours following randomization
Secondary	Lung B-line reduction		within 72 hours following randomization
Secondary	The change of width of inferior vena cava		within 72 hours following randomization
Secondary	Incidence of hypotension during prolonged hemodialysis		within 72 hours following randomization
Secondary	Blood pressure variability during the prolonged hemodialysis		within 72 hours following randomization
Secondary	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
Secondary	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