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Evaluating the chloride levels and pH values following Sterofundin and Plasmalyte infusion in elective major abdominal surgery

Comparison of serum chloride and pH between Sterofundin and Plasmalyte in elective major abdominal surgery, a randomized non inferiority clinical trial - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/069723
Enrollment
92
Registered
2024-07-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Sterofundin: Balanced salt solution with relatively high chloride concentration and low Strong ion difference Control Intervention1: Plasmalyte: Balanced salt solution with relatively l

Sponsors

Postgraduate Institute of Medical Education and Research Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients between age 18 to 70 years undergoing elective major abdominal surgery (more than 2 hours of projected operating time) ASA-PS class 1, 2 and 3

Exclusion criteria

Exclusion criteria: Patients who are hemodynamically unstable preoperatively Presence of preoperative metabolic acidosis (arterial pH lower than 7.2, lactate over 2 mmol per L, bicarbonate less than 16 mEq/L) Acute and, or chronic kidney disease Presence of preoperative fluid overload (pleural, pericardial effusion, ascites)

Design outcomes

Primary

MeasureTime frame
To estimate the difference in serum chloride and pH at the end of major abdominal surgery between the sterofundin and plasmalyte groupTimepoint: At the time of skin closure and before extubation

Secondary

MeasureTime frame
To compare blood gas parameters (HCO3-, BE, pCO2, pO2), electrolytes (Na+, K+, Ca++, Mg++) and lactate at the end of surgery.Timepoint: At the end of surgery;To compare the difference in strong ion difference using stewarts approachTimepoint: At the time of skin closure and before extubation;To compare the prevalence of postoperative AKI as per KDIGO criteriaTimepoint: At the end of postoperative day 7;To compare the total volume of intraoperative crystalloids, colloids and blood products used.Timepoint: Intra operative period;To compare the Vasoactive Inotrope scores between the groupsTimepoint: At the end of surgery

Countries

India

Contacts

Public ContactVenkata Ganesh

Post Graduate Institute of Medical Research

saravanakmr.doc@gmail.com8870075889

Outcome results

None listed

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