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A multicenter, randomized controlled study of intelligent software assisted fluid resuscitation in patients with septic shock

A multicenter, randomized controlled study of intelligent software assisted fluid resuscitation in patients with septic shock

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076796
Enrollment
Unknown
Registered
2023-10-18
Start date
2023-10-20
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

Septic Shock

Interventions

Intervention group:Intelligent software assisted fluid resuscitation treatment
Control group:Traditional fluid resuscitation treatment

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participants must meet all the following conditions to be included in this study: (1) Age = 18; (2) Sign informed consent; (3) Meet the sepsis 3.0 diagnostic criteria issued by the Society of Critical Care Medicine (SCCM) and the European Society of Intensive Care Medicine (ESICM); (4)The lactate level is greater than 2mmol/L and the intravenous infusion volume has reached at least 20mL/kg, but vasopressor drugs are still needed to maintain mean arterial pressure (MAP) = 65mmHg; (5) Diagnosed within 6 hours before enrollment.

Exclusion criteria

Exclusion criteria: 1: Pregnant women 2: Unstable circulatory caused by active bleeding 3: Clearly diagnosed the following diseases: acute cerebrovascular disease or acute coronary syndrome or acute poisoning 4: Absolute contraindications for central venous catheterization in the chest or neck 5: Immediate surgery or dialysis within 6 hours 6: Unable to receive and complete informed consent within 6 hours of being diagnosed with sepsis 7: Incomplete acceptance of various standard bundled treatments.

Design outcomes

Primary

MeasureTime frame
All-cause mortality on the 28th day after randomization;—

Secondary

MeasureTime frame
The proportion of patients who require mechanical ventilation and kidney replacement therapy;Proportion of acute kidney injury;Proportion of?intra-abdominal hypertension;Lactate compliance rate at the 8th hour;Possible factors for software compliance and inconsistent decision-making;Fluid balance;Lactate clearance rate at the 8th hour;Fluid resuscitation volume at the 8th hour;Mortality (including ICU mortality, hospital mortality, and 90 day mortality);Length of stay in ICU and hospital;SOFA score and APACHE II score;Days without MV, vasopressor drugs, and RRT within 28 days;—

Countries

China

Contacts

Public ContactHongping Qu

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

hongpingqu0412@hotmail.com+86 136 4180 1889

Outcome results

None listed

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