Evaluating the serum chloride and pH levels following Sterofundin and Plasmalyte infusion in the resuscitation of critically ill patients in the ICU

Comparison of serum chloride and pH between Sterofundin and Plasmalyte in the resuscitation of critically ill patients in the ICU: A Bayesian Adaptive Randomized Non-Inferiority Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087390

Enrollment

102

Registered

2025-05-22

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Health Condition 1: E872- Acidosis Health Condition 2: E860- Dehydration Health Condition 3: E861- Hypovolemia Health Condition 4: O- Medical and Surgical

Interventions

Intervention1: Sterofundin: Balanced salt solution with relatively high chloride concentration and low Strong ion difference. Administered intravenously for the first 24 hours in ICU as resuscitation

Eligibility

Inclusion criteria

Inclusion criteria: Patients of 18 years of age and above presenting to the ICU in shock requiring fluid resuscitation

Exclusion criteria

Exclusion criteria: Burns/ trauma patients Chronic kidney disease on multiple hemodialysis Presence of fluid overload (pleural, pericardial effusion, ascites) Patients in cardiogenic shock Do not resuscitate (DNR) patients

Design outcomes

Primary

Measure	Time frame
To estimate the difference in serum chloride and pH at the end of resuscitation between the two groups, Sterofundin and Plasmalyte and demonstrate non-inferiorityTimepoint: At the end of 24 hours resuscitation in the ICU	—

Secondary

Measure	Time frame
To compare the strong ion difference in the two groups using Stewarts approachTimepoint: At the end of 24 hours resuscitation in the ICU;To compare the total volume of intravenous crystalloids, colloids and blood products used in resuscitationTimepoint: At the end of 24 hours resuscitation in the ICU;To compare the Vasoactive Inotrope scores between the two groupsTimepoint: At the end of 24 hours resuscitation in the ICU;To compare blood gas parameters (HCO3-, BE, pCO2, pO2), electrolytes (Na+, K+, Ca++, Mg++) and lactate levelsTimepoint: At first hour, 4 hours, 6 hours, 12 hours and 24 hours of resuscitation;To compare the prevalence of acute kidney injury as per KDIGO criteriaTimepoint: At the end of 24 hours resuscitation and 7 days in the ICU	—

Measure

Time frame

To compare the strong ion difference in the two groups using Stewarts approachTimepoint: At the end of 24 hours resuscitation in the ICU;To compare the total volume of intravenous crystalloids, colloids and blood products used in resuscitationTimepoint: At the end of 24 hours resuscitation in the ICU;To compare the Vasoactive Inotrope scores between the two groupsTimepoint: At the end of 24 hours resuscitation in the ICU;To compare blood gas parameters (HCO3-, BE, pCO2, pO2), electrolytes (Na+, K+, Ca++, Mg++) and lactate levelsTimepoint: At first hour, 4 hours, 6 hours, 12 hours and 24 hours of resuscitation;To compare the prevalence of acute kidney injury as per KDIGO criteriaTimepoint: At the end of 24 hours resuscitation and 7 days in the ICU

—

Countries

India

Contacts

Public ContactVenkata Ganesh

Post Graduate Institute of Medical Education and Research, Chandigarh

charvickkundal@gmail.com8447862186

Outcome results

None listed

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