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An Open-label Randomized Controlled Study on the Effects of different Net Ultrafiltration Strategy on Fluid Balance and Prognosis in Patients with Septic Shock

An Open-label Randomized Controlled Study on the Effects of different Net Ultrafiltration Strategy on Fluid Balance and Prognosis in Patients with Septic Shock

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083804
Enrollment
Unknown
Registered
2024-05-04
Start date
2024-05-06
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic shock

Interventions

Active net ultrafiltration strategy group:After enrollment, the initial net ultrafiltration rate is set at 0.5 ml/kg.h. After assessing the patients tolerance, it is adjusted upward by 0.5 ml/kg.h eve
Restricted net ultrafiltration strategy group:After enrollment, the initial net ultrafiltration rate is also set at 0.5 ml/kg.h. After assessing the patients tolerance, it is adjusted upward by 0.5 ml

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. ICU hospitalized patients diagnosed with septic shock Septic shock diagnosis aligning with the 2016 third edition of the international consensus definitions for sepsis and septic shock (Sepsis 3.0). 2. Meeting the diagnostic criteria for Acute Kidney Injury (AKI) (KDIGO Stage 3) Diagnosis of acute kidney injury conforms to the standards set forth by the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. 3. Age: 18 years or older 4. Clinical judgment by physicians indicating the need for continuous renal replacement therapy for fluid management 5. Regardless of patient consciousness or cooperation, willingness of the patient or guardian to participate in the study and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Respiratory failure due to pulmonary edema and volume overload. 2. Clinical judgment by the attending physician indicating inadequate conditions for fluid removal. 3. Patients with severe obesity (body weight greater than 100 kg). 4. Patients with a history of renal failure who regularly undergo hemodialysis. 5. Patients who received continuous renal replacement therapy with fluid removal in other treatment units before ICU admission. 6. Patients receiving ECMO therapy. 7. Patients in critical condition, expected to die within 48 hours, or with a SOFA score = 15, or APACHE II score = 35, or patients refusing active treatment. 8. Expected duration of CRRT application is less than 24 hours. 9. Pregnant or lactating women. 10. Participants who have participated in other interventional clinical trials within the past 30 days.

Design outcomes

Primary

MeasureTime frame
Cumulative fluid balance;

Secondary

MeasureTime frame
All-cause mortality;non-renal SOFA score;

Countries

China

Contacts

Public ContactJin Lin

Beijing Friendship Hospital, Capital Medical University

jin0419@hotmail.com+86 136 9326 1242

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026