Clinical trial NCT06373575: IVC and Lung Ultrasound B-lines Guided Decongestion in Critically Ill ESKD Patients With Heart Failure
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: End-stage Renal Disease
Keywords: Kidney Failure, Chronic
heart failure
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Improvement in pulmonary congestion score
timeFrame: within 72 hours following randomization
measure: Improvement in heart failure symptoms score
timeFrame: within 72 hours following randomization
Secondary outcomes:
measure: Total ultrafiltration volume
timeFrame: within 72 hours following randomization
measure: Mean ultrafiltration rate during prolonged hemodialysis
timeFrame: within 72 hours following randomization
measure: Fluid balance (total outflow - total inflow)
timeFrame: within 72 hours following randomization
measure: Lung B-line reduction
timeFrame: within 72 hours following randomization
measure: The change of width of inferior vena cava
timeFrame: within 72 hours following randomization
measure: Incidence of hypotension during prolonged hemodialysis
timeFrame: within 72 hours following randomization
measure: Blood pressure variability during the prolonged hemodialysis
timeFrame: within 72 hours following randomization
measure: In-hospital mortality
timeFrame: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 100 days
measure: Length of hospital stay
timeFrame: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 100 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Buyun Wu, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: