Health TrialsbyHealthPanel

Diluted and Undiluted Enteral Nutrition

ConditionsCritical IllnessSurgeryEnteral Feeding IntoleranceGastro-Intestinal DisorderQuality of Life
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMedical University of Lublin

About this trial

Adult patients after elective major abdominal surgeries who are planned to be admitted to the Intensive Care Unit (ICU) can be included in the trial.

Each patient will be fed via the gastrointestinal tract. Half of the patients will receive enteral nutrition (EN) with additional fluids, and the rest will receive undiluted EN.

The primary aim of this study is feeding intolerance assessment in both groups of patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled for major abdominal surgery requiring ICU admission

Having access to the GI tract (gastric or jejunal)

Planned to be fed enterally

Disqualifiers

Patients unable to give informed consent

After emergency surgeries

Without access to the GI tract

Individuals with contraindications to EN, such as short bowel syndrome, uncompensated shock, acidosis (pH < 7.1; lactate > 5 mmol/l), bleeding from the upper GI tract, obstruction, intestinal ischemia, abdominal compartment syndrome

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enteral fluid

    Other intervention

    GNAK will be administered to the gastrointestinal tract with EN in the same volume.

  • Intravenous fluid

    Other intervention

    Undiluted EN will be given to the gastrointestinal tract. GNAK, in the same volume, will be administered intravenously.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Enteral nutrition fluid - ENFExperimental treatment 1 intervention
Group B: Intravenous fluid - IVFExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants having nausea and vomiting

Incidents of nausea and vomiting (nausea measured with a 4-point verbal descriptive scale (0=no nausea, 1=mild, 2=moderate, 3=severe))

Time frame
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
2

Number of participants having diarrhea

Incidents of diarrhea (≥ three loose stools per day)

Time frame
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
3

Number of participants having increased gastric residual volume

Increased gastric residual volume (\> 500 ml of gastric aspirate/ 6 hours). Only in patients after lower GI tract surgeries (with intact stomach and gastric feeding)

Time frame
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
4

Number of participants in whom target EN will not be achieved

Achieving target EN on day three and later: 80% of protein requirements according to ESPEN (1.3/kg of ideal body weight (patients BMI \< 30) or adjusted body weight, BMI ≥ 30)

Time frame
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

Secondary outcomes

1

Days of support with PN

Days of support with parenteral nutrition during the ICU stay.

Time frame
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
2

Contribution of PN in total nutrition

Percentage contribution of parenteral nutrition in total patient feeding understand as protein demands

Time frame
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
3

Insulin consumption

Insulin consumption - units per day and total per stay

Time frame
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
4

Electrolyte supplementation

Electrolyte supplementation - potassium, phosphorus, calcium, and magnesium in mmol/ stay

Time frame
From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Lublin

Lead sponsor

Nutricia Fundation

Collaborator

Catholic University of Lublin

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: