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To study about the effect of giving a protein called albumin in patients with inner abdominal wall inflammation

Early goal directed albumin administration in patients with secondary peritonitis: A single centre, open labelled randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059801
Enrollment
110
Registered
2023-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

Interventions

Intervention1: Albumin group: Patients in the intervention group will be receiving 20% albumin as an infusion at the rate of 10ml/hr to target serum albumin level of more than 3g/dl. Maximum volume t

Sponsors

All India Institute of Medical Sciences, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Written informed consent 2. Within 24 hours of diagnosis of secondary peritonitis 3. Serum albumin level less than 3 g/dl

Exclusion criteria

Exclusion criteria: 1. History of allergy to albumin 2. Pregnant women 3. Presence of volume overload [ as assessed by the physician] 4.Conditions in which albumin is clinically indicated – Nephrotic syndrome Burns Intestinal malabsorption syndrome Severe liver cirrhosis [ Child Pugh score – C] Congestive heart failure [ NYHA class of 3 or 4 ]

Design outcomes

Primary

MeasureTime frame
To assess the effect of albumin administration on organ function as defined by a delta Sequential Organ Failure Assessment score [SOFA].Timepoint: 1 week from the day of randomisation

Secondary

MeasureTime frame
1. Hospital length of stay Timepoint: Undefinable;2. 28-day mortalityTimepoint: 28 days from the day of randomisation;3. Cumulative fluid balanceTimepoint: 1 week from the day of randomisation;4. Incidence of post operative complicationsTimepoint: 1 week from the day of randomisation;5. Feeding toleranceTimepoint: 1 week from the day of randomisation

Countries

India

Contacts

Public ContactDr Balaji Nagarajan

All India Institute of Medical Sciences, New Delhi

rahulanand00@gmail.com9013082271

Outcome results

None listed

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