Skip to content

Plasmalyte or normal saline: the future of IV fluids.

Comparison of the effect of Plasmalyte and Normal saline on intraoperative inotropes and vasopressors requirements in patients undergoing emergency gastrointestinal perforation surgery- A pragmatic randomised controlled trial - Nil

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068479
Enrollment
126
Registered
2024-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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: Plasmalyte: It is given intravenously as maintenance and resuscitative fluid therapy in the plasmalyte group. This is given from the onset of surgery till the surgery is completed. Volu

Sponsors

Jipmer intramural grant
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) American Society of Anesthesiologists (ASA) physical status I, II, III and IV 2) Patient undergoing emergency gastrointestinal perforation surgery

Exclusion criteria

Exclusion criteria: 1) Patient already receiving mechanical ventilation 2) Patient already receiving inotrope 3) Acute or chronic preexisting kidney disease 4) Uncontrolled diabetes mellitus/patients requiring insulin therapy 5) History of known anaphylactic reaction 6) Hyperkalemia 7) patients with hepatic dysfunction (total bilirubin above 2mg/dl, sgot and sgpt values more than 2 times normal values)

Design outcomes

Primary

MeasureTime frame
To determine and compare the effect of plasmalyte and 0.9% saline on intraoperative vasopressors and inotropes requirements undergoing emergency gastrointestinal perforation surgery.Timepoint: At the end of study. (2yrs approx)

Secondary

MeasureTime frame
To compare the effect of predefined composite of renal, cardiovascular and respiratory system complications Timepoint: At the end of study. (2yrs approx;To compare the effect on acute kidney injury marker (kidney injury molecule-1) Timepoint: At the end of study. (2yrs approx);To compare the effect on in-hospital mortality, intensive care unit stay and hospital stayTimepoint: At the end of study. (2yrs approx);To compare the effect on postoperative acid-base status and lactateTimepoint: At the end of study. (2yrs approx)

Countries

India

Contacts

Public ContactDr Suman Lata Gupta

JIPMER

jd0330@jipmer.ac.in9487315913

Outcome results

None listed

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