Achieving nuTritional Target in criticAlly Ill patieNts With iMpairEd gastroiNtesTinal Dysfunction

Summary

Clear study hypothesis / research question

It has already been proven that a prolonged negative energy balance during intensive care stay is an independent risk factor for mortality. Although it was thought that achivieng optimal delivery of calories will prevent nutritional deficits in critically ill patients, published randomized controlled trials failed to confirm this hypothesis.

Combinging enteral and parenteral support may be an efficent strategy to reach nutritional target in critically ill patients. According to the current guidelines the use of suplemental parenteral nutrition (SPN) should be considered when energy targets are not achieved by enteral (EN) route, however, no clear data regarding timing, amount and composition is specified. Moreover, based on recente published data overfeeding should also be avoided, considering the negative impact on outcome.

Nutritional support for critically ill patients was focused more on preventing caloric and protein deficits and no great emphasis was placed on the efficiency of intestinal absorption. Gastrointestinal dysfunction is a prevalent reported complication that may contribute to falling short of meeting nutritional goals. This encompasses a wide spectrum of symptoms, such as impaired gastric emptying, ileus or impaired intestinal absorbtion, exposing patients to feeding intolerance, malnutrition and worse outcomes. No standard definition and monitoring techniques are so far available for the diagnostic of feeding intolerance. Although increased gastric residual volume (GRV) is the most used parameter for highlighting feeding intolerance, a controversy regarding the adequate threshold of GRV persists. Acetaminophen absorption test has been previously proposed as a diagnostic tool to asses impaired gastric emptying and intestinal absorbtion.

Besides intestinal absorbtion, efficient utilization of macronutients should also be assessed, considering that critically ill patients have varying metabolic conditions and may not be able to metabolically handle adminsitered substrates. As a result body composition analysis should be taken into account in order to obtain a dynamic quantification, especially, of the mucle mass compartiments.

Therefore the following low-interventional study is designed to investigate the hypothesis regarding energy and protein intake achievement in critically ill patients with diagnosed impaired gastrointestinal dysfunction to whom tailored nutritional support is administered.

Taking into account that we aim to identify patients with early-phase gastrointestinal dysfunction impaired gastric emptying and reduced intestinal absorbtion (diagnosed using ultrasound gastric residual volume and byacetaminiphen absorbtion test) will serve as defining factors. Patients will be randomized to receive nutritional support either according to the EN protocol or enteral trophic feed + SPN protocol.

Differences in rectus femoris thickness measured on admission, on day 10 and 15, variation of lean body mass measured by bioelectrical impedance on admission on day 10 and 15, and differences between groups in muscle function using handgrip dynamometer will also be evaluated in both groups.

Conditions

• Parenteral Nutrition
• Gastroparesis
• Gastrointestinal Dysfunction
• Protein Deficiency
• Critical Illness

Interventions

DIETARY_SUPPLEMENT

Supplemental Parenteral Nutrition (SPN)

Nutritional targets are based on ESPEN guidelines recommendation (calories administration based on indirect calorimetry study, proteins 1.3 g/kg/day). From the first day of ICU admission indirect calorimetry will be performed daily in order to evaluate energy requirements. On the fourth day, the patient will undergo a gastric residual volume measurement and a paracetamol absorption test. If gastrointestinal dysfunction is detected, the patient will be assigned to a study group based on the randomization protocol. The SPN group will gradually initiate supplemental parenteral nutrition in order to achieve the target of 80% by the fifth day. Trophic feed will be administered to cover the remaining 20% of the targeted nutrition intake.

Sponsors & Collaborators

• Fresenius Kabi

  collaborator INDUSTRY

• Carol Davila University of Medicine and Pharmacy

  collaborator OTHER

• Bucharest Emergency Hospital

  collaborator OTHER

• Romanian Society for Enteral and Parenteral Nutrition

  lead OTHER

Principal Investigators

• Cristian Cobilinschi, MD, PhD · Bucharest Emergency Hospital

• Liliana Mirea, Md PhD · Bucharest Emergency Hospital

• Radu Tincu, MD PhD · Bucharest Emergency Hospital

• Ioana Grințescu, Profesor · Carol Davila University of Medicine and Pharmacy

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Romania

Study Locations