Achieving nuTritional Target in criticAlly Ill patieNts With iMpairEd gastroiNtesTinal Dysfunction

NCT06510348 | Recruiting DMC

• 1 other identifier: ATTAINMENTstudy
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

gastrointestinal dysfunction; supplemental parenteral nutrition; parenteral nutrition; enteral nutrition; critically ill; protein intake; calorie intake; gastroparesis; malabsorption

Outcome Measures

Primary Outcomes (2)

• Differences in the attainment (in percentage) of daily calorie

  Differences in the attainment (in percentage) of daily calorie pre-set targets\* calculated from the rest energy expenditure measured (mREE) using indirect calorimetry (IC) between the EN and SPN groups. \*pre-set targets are defined according to the described nutritional protocol (see below Section e. Nutritional protocol) as 25 % of the energy target determined by indirect calorimetry by day 2, 50% by day 3 to 4 and 75 % at day 4. After day 4 the pre-set target is gradually increased to 100 %.

  day 15

• Differences in the attainment (in percentage) of daily protein

  Differences in the attainment (in percentage) of daily protein pre-set targets\* calculated from the rest energy expenditure measured (mREE) using indirect calorimetry (IC) between the EN and SPN groups. \*pre-set targets are defined according to the described nutritional protocol (see below Section e. Nutritional protocol) as 25 % of the energy target determined by indirect calorimetry by day 2, 50% by day 3 to 4 and 75 % at day 4. After day 4 the pre-set target is gradually increased to 100 %.

  day 15

Secondary Outcomes (10)

• Differences in rectus femoris thickness measured on admission, on day 10 and 15

  day 15

• Variation of phase angle between two groups

  day 15

• Variation of lean body mass measured by bioelectrical

  day 15

• muscle force measured on day 15

  day 15

• energy adequacy

  day 15

Study Arms (2)

EN group

NO INTERVENTION

enteral nutrition intake will progressively be increased according to the gastrointestinal tolerance (evaluated based on ultrasound guided gastric residual volume measurement) until the target of 100% is attained following admission to the ICU.

Supplemental parenteral nutrition (SPN) group

EXPERIMENTAL

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.

Dietary Supplement: Supplemental Parenteral Nutrition (SPN)

Interventions

Supplemental Parenteral Nutrition (SPN) DIETARY_SUPPLEMENT

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.

Supplemental parenteral nutrition (SPN) group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Romanian Society for Enteral and Parenteral Nutrition: lead
• Fresenius Kabi: collaborator
• Carol Davila University of Medicine and Pharmacy: collaborator
• Bucharest Emergency Hospital: collaborator

Study Sites (1)

Clinical Emergency Hospital of Bucharest

Bucharest, Romania

RECRUITING

Related Publications (7)

• Berger MM, Soguel L, Charriere M, Theriault B, Pralong F, Schaller MD. Impact of the reduction of the recommended energy target in the ICU on protein delivery and clinical outcomes. Clin Nutr. 2017 Feb;36(1):281-287. doi: 10.1016/j.clnu.2015.12.002. Epub 2015 Dec 28.

  PMID: 26775753 BACKGROUND

• Chapman MJ, Deane AM. Gastrointestinal dysfunction relating to the provision of nutrition in the critically ill. Curr Opin Clin Nutr Metab Care. 2015 Mar;18(2):207-12. doi: 10.1097/MCO.0000000000000149.

  PMID: 25603226 RESULT

• Berger MM, Pantet O, Jacquelin-Ravel N, Charriere M, Schmidt S, Becce F, Audran R, Spertini F, Tappy L, Pichard C. Supplemental parenteral nutrition improves immunity with unchanged carbohydrate and protein metabolism in critically ill patients: The SPN2 randomized tracer study. Clin Nutr. 2019 Oct;38(5):2408-2416. doi: 10.1016/j.clnu.2018.10.023. Epub 2018 Nov 5.

  PMID: 30448193 RESULT

• Berger MM, Burgos R, Casaer MP, De Robertis E, Delgado JCL, Fraipont V, Goncalves-Pereira J, Pichard C, Stoppe C. Clinical nutrition issues in 2022: What is missing to trust supplemental parenteral nutrition (SPN) in ICU patients? Crit Care. 2022 Sep 10;26(1):271. doi: 10.1186/s13054-022-04157-z.

  PMID: 36088342 RESULT

• Toledo DO, Freitas BJ, Dib R, Pfeilsticker FJDA, Santos DMD, Gomes BC, Silva-Jr JM. Peripheral muscular ultrasound as outcome assessment tool in critically ill patients on mechanical ventilation: An observational cohort study. Clin Nutr ESPEN. 2021 Jun;43:408-414. doi: 10.1016/j.clnesp.2021.03.015. Epub 2021 Apr 6.

  PMID: 34024548 RESULT

• Moonen HPFX, Van Zanten ARH. Bioelectric impedance analysis for body composition measurement and other potential clinical applications in critical illness. Curr Opin Crit Care. 2021 Aug 1;27(4):344-353. doi: 10.1097/MCC.0000000000000840.

  PMID: 33967207 RESULT

• Reintam Blaser A, Preiser JC, Fruhwald S, Wilmer A, Wernerman J, Benstoem C, Casaer MP, Starkopf J, van Zanten A, Rooyackers O, Jakob SM, Loudet CI, Bear DE, Elke G, Kott M, Lautenschlager I, Schaper J, Gunst J, Stoppe C, Nobile L, Fuhrmann V, Berger MM, Oudemans-van Straaten HM, Arabi YM, Deane AM; Working Group on Gastrointestinal Function within the Section of Metabolism, Endocrinology and Nutrition (MEN Section) of ESICM. Gastrointestinal dysfunction in the critically ill: a systematic scoping review and research agenda proposed by the Section of Metabolism, Endocrinology and Nutrition of the European Society of Intensive Care Medicine. Crit Care. 2020 May 15;24(1):224. doi: 10.1186/s13054-020-02889-4.

  PMID: 32414423 RESULT

MeSH Terms

Conditions

Hyperphagia; Gastroparesis; Protein Deficiency; Critical Illness; Malabsorption Syndromes

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Intestinal Diseases; Metabolic Diseases

Study Officials

• Cristian Cobilinschi, MD, PhD

  Bucharest Emergency Hospital

  PRINCIPAL INVESTIGATOR

• Liliana Mirea, Md PhD

  Bucharest Emergency Hospital

  STUDY DIRECTOR

• Radu Tincu, MD PhD

  Bucharest Emergency Hospital

  STUDY CHAIR

• Ioana Grințescu, Profesor

  Carol Davila University of Medicine and Pharmacy

  STUDY CHAIR

Central Study Contacts

Cristian Cobilinschi, MD, PhD

CONTACT

+40765018776; cristian.cobilinschi@umfcd.ro

Liliana Mirea, MD, PhD

CONTACT

llmirea@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD,

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)