- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04567641
Early Nutrition Impact on Post Abdominal Surgery Outcome
Impact of Early Enteral & Parenteral Nutrition on Post-operative Outcome After Abdominal Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Enteral Nutrition
|
Forty patients (50%) received enteral nutrition 6 hours after surgical procedures and 40 patients (50%) received parenteral nutrition 6 hours after surgical procedures.
|
|
Parenteral nutrition
|
Forty patients (50%) received enteral nutrition 6 hours after surgical procedures and 40 patients (50%) received parenteral nutrition 6 hours after surgical procedures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gastro-intestinal tolerance: vomitting or diarrhea
Time Frame: 7 days
|
number of participants who develop nausea, vomitting or diarrhea
|
7 days
|
|
Refeeding syndrome; hypokalemia and hypophosphatemia
Time Frame: 7 days
|
number of participants who develop hypokalemia and hypophosphatemia
|
7 days
|
|
length of ICU stay
Time Frame: 7 days
|
measurement of days of ICU stay
|
7 days
|
|
duration of mechanical ventilation.
Time Frame: 7 days
|
measurement of days of mechanical ventilation
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
3 months survival after discharge .
Time Frame: 90 days
|
measurement of the rate of survival within 3 months between participants
|
90 days
|
|
re-admission within 30 days
Time Frame: 30 days
|
measurement of the rate of hospital re-admission within 30 days between participants
|
30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MS-311-2016
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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