Trial Outcomes & Findings for Hypocaloric Nutrition in Critically Ill Patients (NCT NCT01531335)

Results Overview

SOFA score evaluates six systems: respiratory, cardiovascular, coagulation, Central Nervous System, liver and renal. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

80 participants

Primary outcome timeframe

48 hours since nutritional regime starts

Results posted on

2015-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Care Patients will receive normal nutritional regime of around 25 kcal per kg. Standard care: 25 kcal per kg of body weight	Hypocaloric Hyperproteic Nutrition 15 kcal per kg of body weight and 1.7 grams of protein per kg Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg.
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hypocaloric Nutrition in Critically Ill Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Care n=40 Participants Patients will receive normal nutritional regime of around 25 kcal per kg. Standard care: 25 kcal per kg of body weight	Hypocaloric Hyperproteic Nutrition n=40 Participants 15 kcal per kg of body weight and 1.7 grams of protein per kg Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg.	Total n=80 Participants Total of all reporting groups
Age, Continuous	55.7 years STANDARD_DEVIATION 19.5 • n=5 Participants	53.3 years STANDARD_DEVIATION 19.5 • n=7 Participants	54.5 years STANDARD_DEVIATION 19.5 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Region of Enrollment Colombia	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours since nutritional regime starts

SOFA score evaluates six systems: respiratory, cardiovascular, coagulation, Central Nervous System, liver and renal. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).

Outcome measures

Outcome measures
Measure	Standard Care n=40 Participants Patients will receive normal nutritional regime of around 25 kcal per kg. Standard care: 25 kcal per kg of body weight	Hypocaloric Hyperproteic Nutrition n=40 Participants 15 kcal per kg of body weight and 1.7 grams of protein per kg Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg.
SOFA (Sequential Organ Failure Assessment) Score	0.7 units on a scale Standard Deviation 2.8	1.7 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Daily until day 21 or discharge from ICU

This is an indirect measure of glycemic control, and is reported as a daily average.

Outcome measures

Outcome measures
Measure	Standard Care n=40 Participants Patients will receive normal nutritional regime of around 25 kcal per kg. Standard care: 25 kcal per kg of body weight	Hypocaloric Hyperproteic Nutrition n=40 Participants 15 kcal per kg of body weight and 1.7 grams of protein per kg Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg.
Insulin Requirements	14 International Unit of insulin Standard Deviation 22.1	10.4 International Unit of insulin Standard Deviation 17.8

Adverse Events

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hypocaloric Hyperproteic Nutrition

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

Dr Saul Rugeles

Pontificia Universidad Javeriana

Phone: 5715946161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place