Skip to main content
OpenTrials
Completed

NCT Number: NCT04567641

Early Nutrition Impact on Post Abdominal Surgery Outcome

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Nutrition

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Gastro-intestinal tolerance: vomitting or diarrhea

    Time frame: 7 days

    number of participants who develop nausea, vomitting or diarrhea

  2. Refeeding syndrome; hypokalemia and hypophosphatemia

    Time frame: 7 days

    number of participants who develop hypokalemia and hypophosphatemia

  3. length of ICU stay

    Time frame: 7 days

    measurement of days of ICU stay

  4. duration of mechanical ventilation.

    Time frame: 7 days

    measurement of days of mechanical ventilation

Secondary outcomes

  1. 3 months survival after discharge .

    Time frame: 90 days

    measurement of the rate of survival within 3 months between participants

  2. re-admission within 30 days

    Time frame: 30 days

    measurement of the rate of hospital re-admission within 30 days between participants

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Impact of Early Enteral & Parenteral Nutrition on Post-operative Outcome After Abdominal Surgery

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Sep 28, 2020
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.