Effect of Erythromycin in decreasing gastric volume in severe head injury patients-A Randomised Control Trial
Phase 3
- Conditions
- Health Condition 1: S00-T88- Injury, poisoning and certain other consequences of external causes
- Registration Number
- CTRI/2024/08/072480
- Lead Sponsor
- AIIMSNew Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1Severe 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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Adverse drug effects associated with erythromycin: rash, diarrhoea, cardiac arrhythmia <br/ ><br>Timepoint: 24 hours;Incidence of feeding intolerance <br/ ><br>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 – <br/ ><br>-Raised ICP <br/ ><br>-Glycemic control <br/ ><br>-Electrolyte imbalances <br/ ><br>-Use of Sedative agents <br/ ><br>-Use of vasopressor/ ionotropic agents <br/ ><br> <br/ ><br>Timepoint: 6 hours;To study the effect of erythromycin on peristaltic movement <br/ ><br> <br/ ><br>Timepoint: 6 hours