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Search / Trial NCT06510348

Achieving nuTritional Target in criticAlly Ill patieNts With iMpairEd gastroiNtesTinal Dysfunction

Launched by ROMANIAN SOCIETY FOR ENTERAL AND PARENTERAL NUTRITION · Jul 14, 2024

Trial Information

Current as of May 22, 2025

Recruiting

Keywords

Gastrointestinal Dysfunction Supplemental Parenteral Nutrition Parenteral Nutrition Enteral Nutrition Critically Ill Protein Intake Calorie Intake Gastroparesis Malabsorption

ClinConnect Summary

This clinical trial is studying the best ways to provide nutritional support to critically ill patients who have difficulty digesting food. Researchers want to find out if a combination of feeding through a tube (enteral nutrition) and nutrition delivered through an IV (parenteral nutrition) can help these patients meet their energy and protein needs more effectively. The trial will focus on patients who are on mechanical ventilation and have been experiencing problems with their stomach and intestines, which can make it hard for them to absorb nutrients properly.

To participate in the trial, individuals must be adults over 18 years old, have been on mechanical ventilation for more than four days, and show signs of impaired absorption in their digestive system. Participants will be randomly assigned to receive either standard nutritional support or a combination of tube feeding and IV nutrition. Throughout the study, researchers will monitor changes in muscle mass and strength to see how well the different nutritional approaches work. This trial aims to improve care for critically ill patients by finding tailored nutritional solutions that support their recovery.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • All adults (\> 18 years old)
  • Mechanical ventilation for more than four days,
  • Controlled shock state (hemodynamic and tissue perfusion goals are reached) - Impaired intestinal absorbtion, defiend by both ultrasound measurement of gastric residual volume and paracetamol absorbtion test
  • Exclusion Criteria:
  • patients on non-invasive mechanichal ventilation
  • contraindication for EN for \> 48 h after admission
  • patients with gastrointestinal surgical intervention within 3 months,
  • history of malabsorption, inflammatory bowel disease
  • short bowel syndrom
  • anorexia nervosa
  • gastrointestinal bleeding
  • cirrhosis
  • traumatic brain injury
  • subarahnoidal hemorrhage
  • neoplasia
  • post cardiac arrest patients
  • patients on chronic therapy with corticosteroids
  • pregnant women.

About Romanian Society For Enteral And Parenteral Nutrition

The Romanian Society for Enteral and Parenteral Nutrition (SREN) is a leading professional organization dedicated to advancing the field of clinical nutrition in Romania. Committed to promoting high standards of care, SREN facilitates research, education, and collaboration among healthcare professionals involved in enteral and parenteral nutrition. Through its initiatives, the society aims to enhance patient outcomes by supporting evidence-based practices and fostering innovation in nutritional therapies. SREN plays a pivotal role in shaping clinical guidelines and advocating for the importance of nutritional support in various medical settings.

Locations

Bucharest, , Romania

Patients applied

0 patients applied

Trial Officials

Cristian Cobilinschi, MD, PhD

Principal Investigator

Bucharest Emergency Hospital

Liliana Mirea, Md PhD

Study Director

Bucharest Emergency Hospital

Radu Tincu, MD PhD

Study Chair

Bucharest Emergency Hospital

Ioana Grințescu, Profesor

Study Chair

Carol Davila University of Medicine and Pharmacy

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported