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Effect of 5% albumin based fluid therapy during open abdominal surgery in patients with abdominal infection as compared to balanced salt solutions

Effect of 5% human albumin-based perioperative fluid therapy in perforation peritonitis patients undergoing emergency laparotomy: A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067038
Enrollment
50
Registered
2024-05-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: K650- Generalized (acute) peritonitis Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: 5% human albumin group: 5% human albumin used as intraoperative fluid therapy (during the surgery/ anaesthesia) Control Intervention1: Plasmalyte group: Plasmalyte used as intraoperativ

Sponsors

Sulagna Bhattacharjee
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with perforation peritonitis undergoing emergency laparotomy

Exclusion criteria

Exclusion criteria: 1. Patients refusal to participate in the study 2. Patients undergoing elective laparotomy 3. Pre-existing significant cardiac, renal and hepatic diseases 4. Intraoperative massive blood loss or massive transfusion 5. Patients who are on high dose of vasopressor (defined as noradrenalin 15mcg/min or equivalent).

Design outcomes

Primary

MeasureTime frame
the effect of 5% human albumin based perioperative fluid therapy on postoperative endothelial glycocalyx shedding product syndecan -1, as compared to isotonic balanced salt solutionsTimepoint: At the 24hours postoperative

Secondary

MeasureTime frame
Postoperative hyaluronan, heparan sulphate, TNF- alpha, IL-1, IL-6 & IL-10 between two group of patients. 2. duration of ICU stay, hospital stay & mortality, incidence of postoperative pulmonary complications & acute kidney injury, requirement of postoperative mechanical ventilation between the two groups Timepoint: Postoperative 24hours

Countries

India

Contacts

Public ContactSulagna Bhattacharjee

AIIMS, New Delhi

bhattacharjee.sulagna85@gmail.com9818212531

Outcome results

None listed

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