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Effect of Erythromycin in decreasing gastric volume in severe head injury patients-A Randomised Control Trial

Effect of single dose Erythromycin on gastric residual volume in severe TBI patients-A Randomised Control Trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072480
Enrollment
88
Registered
2024-08-13
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: S00-T88- Injury, poisoning and certain other consequences of external causes

Interventions

Intervention1: Erythromycin: 500 mg erythromycin dissolved in 10 ml water given 1 hour before feed via NG/OG tube Control Intervention1: Placebo: 10 ml of water given via NG/OG tube 1 hour before bolu

Sponsors

AIIMSNew Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Severe TBI (GCS:3-8) 2. Exclusively enteral fed by NG/OG tube 3. On bolus enteral feeding with established feeding pattern 4.Receiving formula feed

Exclusion criteria

Exclusion criteria: 1. Refusal for consent by the patient attenders 2. Severe TBI associated with spinal cord injuries 3. Severe TBI associated with bowel injuries 4. Severe TBI with thoracic injuries 5. Patients on parenteral nutrition. 6. Patients with feeding intolerance 7. Pregnant & lactating mothers 8. Patient with associated renal & hepatic dysfunction 9. Known hypersensitivity reaction with erythromycin.

Design outcomes

Primary

MeasureTime frame
To assess the effect of erythromycin versus placebo on gastric residual volume, measured hourly for 6 hours with Ultrasound after bolus feeding in severe TBI patientsTimepoint: hourly for 6 hours

Secondary

MeasureTime frame
Adverse drug effects associated with erythromycin: rash, diarrhoea, cardiac arrhythmia Timepoint: 24 hours;Incidence of feeding intolerance Timepoint: defined as gastric residual volume of more than 300 ml at the end of 6 hour;To study factors associated with delayed gastric emptying – -Raised ICP -Glycemic control -Electrolyte imbalances -Use of Sedative agents -Use of vasopressor/ ionotropic agents Timepoint: 6 hours;To study the effect of erythromycin on peristaltic movement Timepoint: 6 hours

Countries

India

Contacts

Public ContactChitra Prabha Saun

All India Institute of Medical Sciences, New Delhi

drashishbindra@gmail.com8826417127

Outcome results

None listed

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