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Comparison of conventional SOFA score and SOFA score with lactate in ICU

Prospective addition of lactate to SOFA score- SOFA 2.0 (proposed): A single blinded randomized control study - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/102842
Enrollment
188
Registered
2026-02-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: K929- Disease of digestive system, unspecified Health Condition 2: R99- Ill-defined and unknown cause of mortality Health Condition 3: I958- Other hypotension Health Condition 4: J22- Unspecified acute lower respiratory infection Health Condition 5: S099- Unspecified injury of face and head Health Condition 6: B955- Unspecified streptococcus as the cause of diseases classified elsewhere Health Condition 7: V99- Unspecified transport accident

Interventions

Intervention1: Lactate integrated SOFA score: Patients randomized to this group will have serum lactate levels measured at predefined time points and incorporated into the SOFA score as an additional

Sponsors

Asian Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients diagnosed with sepsis or septic shock Patients with polytrauma or traumatic brain injury Cases of multi-organ failure Expected ICU stay more than 24 hours

Exclusion criteria

Exclusion criteria: Active malignancy Chronic liver disease Diabetic ketoacidosis Pregnancy Patients with established gut ischemia

Design outcomes

Primary

MeasureTime frame
All-cause mortality at 28 daysTimepoint: All-cause mortality at 28 days

Secondary

MeasureTime frame
ICU length of stay Vasopressor free days & ventilator free days Organ dysfunction progression Lactate clearance at 24 & 48 hoursTimepoint: 0hour, 24hours,48hours,72hours

Countries

India

Contacts

Public ContactDebasmita Dash

Asian institute of medical sciences, Faridabad

debasmita0412@gmail.com09930674313

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026