Health Trialsby

Undiluted and Diluted Nutrition

ConditionsCritical Illness Gastro Intestinal Surgery Enteral Feeding Intolerance Gastro-Intestinal Disorder Quality of Lifte

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorJohn Paul II Catholic 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 to assess feeding intolerance in both patient groups.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

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

80 Participants

are divided into 2 treatment groups

Group A: Experimental : Enteral nutrition fluid - ENFExperimental treatment 1 intervention

Group B: Intravenous fluid - IVFExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients having vomiting.

Any incidents of vomiting.

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 who received prokinetic agents.

Administration of prokinetic agents starting with both erythromycin (125mg twice daily enterally) and metoclopramide (10mg three times per day i.v.) due to significant EN intolerance, i.e. ≥ 2 incidents of vomiting/24h; \> 500 mL of gastric volume/6h; presence of gastric contents/nutrition in the endotracheal tube due to regurgitation

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

Number of participants having nausea

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

≥ 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

\> 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 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

Sponsors and contacts

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

John Paul II Catholic University of Lublin

Lead sponsor

Center of Oncology of the Lublin Region

Collaborator

Provincial Specialist Hospital in Lublin

Collaborator

Source ClinicalTrials.gov

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