End-stage Renal Disease
Conditions
Keywords
Kidney Failure, Chronic, heart failure
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.
Interventions
PROCEDURELung 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.
PROCEDUREConventional protocol guidance
Fluid removal using conventional protocol including blood pressure and physical examination
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in heart failure symptoms score | within 72 hours following randomization |
| Improvement in pulmonary congestion score | within 72 hours following randomization |
Secondary
| Measure | Time frame |
|---|---|
| Fluid balance (total outflow - total inflow) | within 72 hours following randomization |
| Lung B-line reduction | within 72 hours following randomization |
| The change of width of inferior vena cava | within 72 hours following randomization |
| Total ultrafiltration volume | 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 |
| 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 |
| Incidence of hypotension during prolonged hemodialysis | within 72 hours following randomization |
| Mean ultrafiltration rate during prolonged hemodialysis | within 72 hours following randomization |
Countries
China
Outcome results
None listed