Trial Outcomes & Findings for Enteral Versus Parenteral Glutamine Supplement (NCT NCT00875797)

Results Overview

Measurement of intestinal permeability using lactulose-mannitol test (L/M test). Intestinal permeability to sugars is an accurate test for detecting intestinal damage. Intestinal permeability of the epithelium to very small sugar molecules such as lactulose/mannitol may give useful information regarding the overall condition of the digestive tract. Mannitol is absorbed transcellularly and lactulose has a paracellular route of absorption. Reduction in mannitol absorption shows reduced surface area and increased lactulose absorption indicates a leaky gut. Lactulose and mannitol are given orally and later determined from the collected urine with HPTLC (high performance thin layer chromatography). The L/M ratio, as a result of lactulose-mannitol tests, is then calculated regarding urine lactulose and mannitol concentrations. Thus, with the lactulose/mannitol test the intestinal permeability changes due to different reasons can be evaluated.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

90 participants

Primary outcome timeframe

4 days after admission to intensive care unit

Results posted on

2014-01-16

Participant Flow

Mechanically ventilated surgical and trauma critically-ill patients, older than 18 years, were enrolled in the study upon admission to ICU.

The patients with anuria or/and intestinal insufficiency (obstruction, discontinuation of intestine or severe paralytic ileus) were excluded from the study

Participant milestones

Participant milestones
Measure	Group P Group P - group with parenterally supplemented glutamine	Group E Group E - group with enterally supplemented glutamine
Overall Study STARTED	45	45
Overall Study COMPLETED	39	42
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Group P Group P - group with parenterally supplemented glutamine	Group E Group E - group with enterally supplemented glutamine
Overall Study Protocol Violation	6	3

Baseline Characteristics

Enteral Versus Parenteral Glutamine Supplement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parenteral Glutamine n=45 Participants parenteral glutamine supplementation	Enteral Glutamine n=45 Participants enteral glutamine supplementation	Total n=90 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Age, Continuous	55.97 years STANDARD_DEVIATION 12.90 • n=5 Participants	51.40 years STANDARD_DEVIATION 20.19 • n=7 Participants	53.60 years STANDARD_DEVIATION 17.13 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	31 Participants n=7 Participants	61 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 days after admission to intensive care unit

Measurement of intestinal permeability using lactulose-mannitol test (L/M test). Intestinal permeability to sugars is an accurate test for detecting intestinal damage. Intestinal permeability of the epithelium to very small sugar molecules such as lactulose/mannitol may give useful information regarding the overall condition of the digestive tract. Mannitol is absorbed transcellularly and lactulose has a paracellular route of absorption. Reduction in mannitol absorption shows reduced surface area and increased lactulose absorption indicates a leaky gut. Lactulose and mannitol are given orally and later determined from the collected urine with HPTLC (high performance thin layer chromatography). The L/M ratio, as a result of lactulose-mannitol tests, is then calculated regarding urine lactulose and mannitol concentrations. Thus, with the lactulose/mannitol test the intestinal permeability changes due to different reasons can be evaluated.

Outcome measures

Outcome measures
Measure	Group P - Parenteral Glutamine n=39 Participants Group P - group with parenterally supplemented glutamine	Group E - Enteral Glutamine n=42 Participants Group E - group with enterally supplemented glutamine
Intestinal Permeability - Lactulose-mannitol(L/M)Test	0.492 L/M ratio Standard Deviation 0.68	0.521 L/M ratio Standard Deviation 0.86

SECONDARY outcome

Timeframe: participants were followed for the duration of ICU stay (average 3 weeks)

Number of infections that occured at participants during study.

Outcome measures

Outcome measures
Measure	Group P - Parenteral Glutamine n=39 Participants Group P - group with parenterally supplemented glutamine	Group E - Enteral Glutamine n=42 Participants Group E - group with enterally supplemented glutamine
Infection Rate at Participants in Both Groups	15 number of infections	12 number of infections

SECONDARY outcome

Timeframe: 6 month

Six month follow up

Outcome measures

Outcome measures
Measure	Group P - Parenteral Glutamine n=39 Participants Group P - group with parenterally supplemented glutamine	Group E - Enteral Glutamine n=42 Participants Group E - group with enterally supplemented glutamine
6-month Survival	31 participants	36 participants

Adverse Events

Group P

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group E

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lidija Kompan, principal Investigator

UMCLjubljana

Phone: 0038651301781

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place