Clinical trial NCT04567641: Early Nutrition Impact on Post Abdominal Surgery Outcome
Official title: Impact of Early Enteral & Parenteral Nutrition on Post-operative Outcome After Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Nutrition
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included patients with age more than 18 years underwent major abdominal surgeries.

Pre-operative nutrition screening was done using Nutritional risk screening (NRS 2000).

Patients were divided into two groups: Group A: 40 patients (50%) received enteral nutrition 6 hours after surgical procedure \& Group B: 40 patients (50%) received parenteral nutrition 6 hours after surgical procedure according to the surgeons preference.

Enteral feeding in group (A) was started 6 hours postoperatively via ryle tube or feeding jejunostomy including proteins (1.5 gm/kg/day) with a caloric value (4.1 kcal/gm), fat (caloric value = 9 kcal/gm) \& carbohydrates.

Parenteral feeding in group (B) was started 6 hours postoperatively using SmofKabiven Peripheral \[FRESENIUS KABI\] : 1200 ml , 38 gm amino acids, 34 gm lipids, 85 gm glucose, osmolarity 850 mosmol/L with total energy approximately 800Kcal.

Brief summary: Introduction: Nutritional support is a vital therapy of most surgical patients. Early initiation via the enteral route has a significant effect on postoperative recovery. The prognostic role of CRP and albumin can be explained by their abilities to reflect inflammation in the acute phase in critical settings and assess the nutritional status of critically ill patients, respectively. This indicates the prognostic value of the CRP/ALB ratio in postoperative patients admitted to the ICU.

Aim of work: Determine the effect of early enteral \& parenteral nutrition on ICU outcome \& nutritional status in postoperative abdominal surgical patients and investigate the effect of enteral \& parenteral nutrition on CRP/albumin ratio as an inflammatory marker \& its correlation with SOFA score.

Methods: A prospective cohort non randomized study included 80 postoperative abdominal surgical patients at Critical Care Department, Cairo University over one year duration. Forty patients (50%) received enteral nutrition 6 hours after surgical procedures and 40 patients (50%) received parenteral nutrition 6 hours after surgical procedures. Nutritional status and inflammatory markers were screened. All patients were followed up during the ICU stay \& up to 3 months. SOFA scoring was done every 48 hours.


Eligibility criteria: Inclusion Criteria:

* postoperative abdominal surgical patients at Critical Care Department, Cairo University over one year duration.
* age between 18-80 years

Exclusion Criteria:

* renal failure
* liver failure
* extensive burns
* hemodynamic instability.

Primary outcomes:
measure: Gastro-intestinal tolerance: vomitting or diarrhea
timeFrame: 7 days
measure: Refeeding syndrome; hypokalemia and hypophosphatemia
timeFrame: 7 days
measure: length of ICU stay
timeFrame: 7 days
measure: duration of mechanical ventilation.
timeFrame: 7 days
Secondary outcomes:
measure: 3 months survival after discharge .
timeFrame: 90 days
measure: re-admission within 30 days
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References: