Preoperative Immunonutrition and Cardiac Patients

NCT03445221 | Completed Phase 2 DMC

• 1 other identifier: Immunonutrition
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

With the progress of cardiac surgery, the indication of cardiac valve replacement has been extended to include severely ill patients, even those with cardiac cachexia caused by long-standing mitral valve disease. Since patients with advanced cardiac functional disability are prone to fall into a low cardiac output state after valve replacement, Those severely ill, cachectic patients may be susceptible to postoperative acute renal failure. Preoperative malnutrition because of poor oral intake significantly increases the risk of adverse events after surgery and leads to increased length of stay. Major operation itself possibly cause the dysfunction of the host homeostasis, defense mechanisms and inflammatory response, which would increase the rate of postoperative complications and prolong hospital stay. Recently, many researchers argued that immunonutritional formulas supplemented with biologically active nutrients were more effective than standard nutrition intervention in improving inflammation, promoting the wound healing and shortening the length of hospital stay (LOS) after operation.

Conditions

Cardiac Function

Keywords

Immunonutrition; Cardiac Patient; Mitral Valve Replacement

Outcome Measures

Primary Outcomes (1)

• Cardiac Fuction

  Serum proBNP (Brain natruritic peptide)

  4 days

Secondary Outcomes (6)

• Inotropic score

  4 days

• Kidney Function

  4 days

• urine output

  2 days

• Hemodynamics

  2 days

• Postoperative Hospital Data

  4 days

Study Arms (2)

Group I

ACTIVE COMPARATOR

Patients will receive preoperative immunonutrition in the form of glutamine) Dipeptiven-Fresenius Kabi) given by intravenous infusion 0.4g/kg/day for 3 days before surgery.

Dietary Supplement: IV Immunonutrition

Group II

ACTIVE COMPARATOR

Patients will continue preoperative oral conventional diet.

Dietary Supplement: Conventional Diet

Interventions

IV Immunonutrition DIETARY_SUPPLEMENT

patients will receive preoperative immunonutrition in the form of glutamine) Dipeptiven-Fresenius Kabi) given by intravenous infusion 0.4g/kg/day for 3 days before surgery.

Group I

Conventional Diet DIETARY_SUPPLEMENT

patients will continue preoperative oral conventional diet.

Group II

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both sex
• Age: 18-60 years.
• Valvular heart disease .
• ASA II,III
• Non-diabetic.
• Elective surgery.

You may not qualify if:

• Pre-existing renal disease(creatinine3.5mg/dl or dialysis)
• Diabetic.
• Off pump surgery.
• Long CBP time \>120 min .
• Previous cardiac surgery.
• Hepatic failure or established cirrhosis.
• Emergency surgery

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Interventions

Immunonutrition Diet

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Khaled M Morsy, MD

  Assistant prof of anesthesia and intensive care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 26, 2018
• Study Start: August 1, 2018
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

EG (1)