Early Nutrition Impact on Post Abdominal Surgery Outcome

NCT04567641 | Completed

• 1 other identifier: MS-311-2016
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Nutrition

Outcome Measures

Primary Outcomes (4)

• Gastro-intestinal tolerance: vomitting or diarrhea

  number of participants who develop nausea, vomitting or diarrhea

  7 days

• Refeeding syndrome; hypokalemia and hypophosphatemia

  number of participants who develop hypokalemia and hypophosphatemia

  7 days

• length of ICU stay

  measurement of days of ICU stay

  7 days

• duration of mechanical ventilation.

  measurement of days of mechanical ventilation

  7 days

Secondary Outcomes (2)

• 3 months survival after discharge .

  90 days

• re-admission within 30 days

  30 days

Study Arms (2)

Enteral Nutrition

Dietary Supplement: postoperative nutrition

Parenteral nutrition

Dietary Supplement: postoperative nutrition

Interventions

postoperative nutrition DIETARY_SUPPLEMENT

Forty patients (50%) received enteral nutrition 6 hours after surgical procedures and 40 patients (50%) received parenteral nutrition 6 hours after surgical procedures.

Enteral Nutrition; Parenteral nutrition

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: September 28, 2020
• Study Start: January 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: January 1, 2019
• Last Updated: September 30, 2020

Record last verified: 2020-09