Benefits of glutamine enriched feed over normal routine feed in traumatic brain injury patients:A double blinded RCT

Completed

Conditions: Head Injured

Registration Number: CTRI/2014/02/004399

Lead Sponsor: AIIMS

Brief Summary: - Head injury patients who met the inclusion criteria were randomly assigned on interventional group and control group by the third party.Subjects in both interventional and control group were started on enteral feed within 24-48 hours after the time of admission as ordered by the physician and the patients in the interventional group were supplemented with 20g of glutamine per day for 10 days along with the normal routine feed.The patients were assigned to two groups by the third party but the investigator was not known about the feeding regimen of each group other than the group name as A or BThe addition of glutamine was only known by the dietician or the corresponding people from the dietetics department and the third party who was doing the randomization.Patients in both groups were assessed for nutritional status (hemoglobin, serum protein, serum albumin, serum urea, mid arm circumference, triceps skin fold thickness and mid arm muscle circumference) on 0day, 5th day and 10th day.Patients in both group were assessed for infectious complications (Total Leucocyte Count, Fever and Culture studies specific to any signs of infection as identified by the treating doctor if there is fever>100F or TLC>10000/mm3) on 0 day, 3rd day, 5th day and 10th day. The number of ventilator days, no of days of ICU stay and no of days of hospitalization were calculated from patient records at discharge.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

Traumatic brain injured patients with GCS 5-12 Body mass index falling between 17-40 Age(18-60) Subjects who give consent to practice.

Exclusion Criteria

Multiple organ system dysfunction Immune suppressive conditions(HIV,TB) Associated trauma such as pulmonary contusion, extremity fracture ,chest or intra-abdominal injuries Cancer or Taking chemotherapy or radiotherapy in last 6 months Chronic Obstructive Pulmonary Disease Renal failure Hepatic dysfunction Previous organ transplantation Pregnancy Indication of Total Parentral Nutrition Previously on antibiotics Chronic alcoholics and smokers.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
nutritional status	on day 3,5 and 10 after initiation of glutamine enriched feed

Secondary Outcome Measures

Name	Time	Method
infectious complications	on day 3,5 and 10 after initiation of glutamine enriched feed

Trial Locations

Locations (1): TC3 ICU & TC5 WARD,JPNATC,AIIMS
🇮🇳
Delhi, DELHI, India
TC3 ICU & TC5 WARD,JPNATC,AIIMS
🇮🇳Delhi, DELHI, India
Dr Sumit Sinha
Principal investigator
9868398244
sumitneuro@gmail.com