Pulmonary-Specific Enteral Nutrition in Mechanically Ventilated Patients With Pneumonia

NCT07892521 | Completed

• 1 other identifier: AMM-PULMONARY-EN-2025
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Pneumonia is a major cause of critical illness and respiratory failure, particularly among patients requiring invasive mechanical ventilation. These patients frequently experience systemic inflammation and metabolic disturbances, which can be assessed using the neutrophil-to-lymphocyte ratio (NLR) and blood lactate levels. Pulmonary-specific enteral nutrition, characterized by a lower carbohydrate and higher fat composition, may help improve respiratory metabolism and modulate inflammatory responses. This double-blind, randomized controlled trial aimed to evaluate the effects of pulmonary-specific enteral nutrition compared with standard enteral nutrition on NLR and blood lactate levels in adult patients with pneumonia requiring invasive mechanical ventilation. Participants were randomly assigned to receive either pulmonary-specific enteral nutrition or standard enteral nutrition. NLR and blood lactate levels were measured on days 1, 3, and 5 to assess changes in inflammatory and metabolic parameters during the intervention period.

Conditions

Pneumonia

Keywords

Pulmonary-Specific Enteral Nutrition; Mechanical Ventilation; Neutrophil-to-Lymphocyte Ratio; Blood Lactate; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Change in Neutrophil-to-Lymphocyte Ratio (NLR) From Baseline to Day 5

  The neutrophil-to-lymphocyte ratio (NLR) was calculated by dividing the absolute neutrophil count by the absolute lymphocyte count obtained from a complete blood count. NLR was assessed at baseline (Day 1), Day 3, and Day 5. The outcome evaluates the change in NLR between baseline and Day 5, with additional assessment of changes between Days 1-3 and Days 3-5. NLR is a dimensionless ratio.

  Baseline (Day 1) and Day 5

Secondary Outcomes (1)

• Change in Blood Lactate Levels From Baseline to Day 5

  Baseline (Day 1) and Day 5

Study Arms (2)

Pulmonary-Specific Enteral Nutrition

EXPERIMENTAL

Participants assigned to this group received pulmonary-specific enteral nutrition (Pulmosol®) through an enteral feeding tube. The formula was administered as the assigned nutritional intervention without combination with the standard hospital enteral formula. Energy delivery was individualized according to clinical requirements and feeding tolerance during the five-day observation period.

Other: Pulmonary-Specific Enteral Nutrition

Standard Enteral Nutrition

ACTIVE COMPARATOR

Participants assigned to this group received the standard hospital enteral nutrition formula (FRS-CLLM) through an enteral feeding tube. Nutritional delivery was individualized according to energy requirements and feeding tolerance, following routine nutritional management during the five-day observation period.

Other: Standard Hospital Enteral Nutrition

Interventions

Pulmonary-Specific Enteral Nutrition OTHER

Pulmonary-specific enteral formula (Pulmosol®) administered through a nasogastric or other enteral feeding tube as the sole assigned enteral formula. Nutritional targets were individualized based on estimated energy requirements, with gradual advancement of feeding toward the full caloric target. The formula contains carbohydrate, protein, fat, and omega-3 fatty acids. Nutritional tolerance was monitored throughout the intervention.

Also known as: Pulmosol

Pulmonary-Specific Enteral Nutrition

Standard Hospital Enteral Nutrition OTHER

Standard hospital enteral nutrition formula, administered through a nasogastric or other enteral feeding tube according to individually estimated energy and protein requirements. Nutritional delivery was progressively adjusted based on clinical condition and feeding tolerance during the five-day observation period.

Standard Enteral Nutrition

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18-80 years requiring mechanical ventilation.
• Diagnosis of severe pneumonia, including community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), or ventilator-associated pneumonia (VAP), based on ATS/IDSA criteria or a PaO2/FiO2 ratio \< 200 mmHg, with all of the following:
• Severe respiratory distress or clinical manifestations of acute respiratory distress syndrome (ARDS) requiring ventilatory support.
• Endotracheal intubation or tracheostomy with mechanical ventilation.
• Indication for full enteral nutritional support through a nasogastric tube (NGT), orogastric tube (OGT), or another enteral feeding route, with the ability to receive liquid enteral nutrition.
• Adequate gastrointestinal tolerance for enteral feeding.
• Written informed consent provided by the participant or a legally authorized representative.

You may not qualify if:

• Pregnancy or breastfeeding.
• Hepatic dysfunction, indicated by elevated serum aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT).
• Severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73 m², significantly elevated blood urea or creatinine levels, or an indication for a protein-restricted diet.
• Contraindications to enteral nutrition, including the need for fasting, dark-colored gastric residuals through a nasogastric tube, postoperative gastrointestinal conditions, or other conditions preventing safe enteral feeding.
• Refusal to participate in the study.

Sponsors & Collaborators

• Universitas Indonesia: lead

Study Sites (1)

Cipto Mangunkusumo National Central General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Pneumonia; Critical Illness

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ceva W Pitoyo

  Ciptomangunkusumo hospital/Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both enteral formulas were provided in identical packaging to maintain blinding during the intervention period. Treatment allocation was concealed from investigators, treating healthcare providers, and outcome assessors.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2026
• First Posted: October 23, 2026
• Study Start: July 28, 2025
• Primary Completion: June 3, 2026
• Study Completion: June 3, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)