PneumoniaNCT07892521
Pulmonary-Specific Enteral Nutrition in Mechanically Ventilated Patients With Pneumonia
A study testing Pulmonary-Specific Enteral Nutrition and Standard Hospital Enteral Nutrition in people with Pneumonia, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Pulmonary-Specific Enteral Nutrition and Standard Hospital Enteral Nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIndonesia
- Study dates
- 28 Jul 2025to 3 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo National Central General Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: A Double-Blind Randomized Controlled Trial of Pulmonary-Specific Enteral Nutrition on Neutrophil-to-Lymphocyte Ratio and Blood Lactate in Mechanically Ventilated Patients With Pneumonia
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.
Read the detailed description
This study was a single-center, double-blind, parallel-group randomized controlled trial conducted in the Intensive Care Unit (ICU) and High Care Unit (HCU) of Cipto Mangunkusumo National Hospital, Jakarta, Indonesia, between January and December 2025.
The study evaluated whether pulmonary-specific enteral nutrition could influence systemic inflammatory and metabolic responses in critically ill adults with pneumonia requiring invasive mechanical ventilation. Eligible patients were adults aged 18-80 years with a diagnosis of pneumonia based on clinical, radiological, and laboratory findings, including community-acquired pneumonia, hospital-acquired pneumonia, and ventilator-associated pneumonia.
Participants were randomly assigned in a 1:1 ratio to receive pulmonary-specific enteral nutrition (Pulmosol®) or standard hospital enteral nutrition. Randomization was performed using a computer-generated block randomization sequence. Both formulas were provided in identical packaging to maintain blinding of investigators, healthcare providers, and outcome assessors.
Enteral nutrition was administered through a nasogastric or orogastric tube. Energy requirements were assessed using indirect calorimetry when available or estimated at approximately 25-30 kcal/kg/day. Nutritional delivery was initiated gradually, targeting approximately 70% of estimated energy requirements during the first three days and advancing toward the full caloric target thereafter. The protein intake target was approximately 1.2-1.5 g/kg/day.
The study assessed the neutrophil-to-lymphocyte ratio (NLR) as an inflammatory biomarker and blood lactate concentration as a metabolic biomarker. Measurements were performed on study days 1, 3, and 5. Changes in these parameters were evaluated within each treatment group and compared between the two groups.
The planned statistical approach included the Friedman test for within-group repeated measurements and the Mann-Whitney U test for between-group comparisons of changes in biomarker levels. Statistical significance was evaluated using a two-sided threshold of p < 0.05.
The study was approved by the Ethics Committee of the Faculty of Medicine, Universitas Indonesia-Cipto Mangunkusumo Hospital (KET-1383/UN2.F1/ETIK/PPM.00.02/2023). Written informed consent was obtained from participants or their legally authorized representatives before enrollment.
- Conditions
- Pneumonia
- Being tested
- Pulmonary-Specific Enteral Nutrition, Standard Hospital Enteral Nutrition
- Keywords
- Pulmonary-Specific Enteral Nutrition, Mechanical Ventilation, Neutrophil-to-Lymphocyte Ratio, Blood Lactate, Critical Illness
- Medical subject headings
- Pneumonia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary-Specific Enteral NutritionOther
Also called Pulmosol
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.
Standard Hospital Enteral NutritionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Hospital Enteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1) and Day 5
Secondary outcomes (1)
Change in Blood Lactate Levels From Baseline to Day 5
Blood lactate concentration was measured in mmol/L at baseline (Day 1), Day 3, and Day 5. The outcome evaluates the absolute change in blood lactate concentration from baseline to Day 5, with additional assessment of changes between Days 1-3 and Days 3-5. Changes were compared between the pulmonary-specific enteral nutrition and standard enteral nutrition groups.
Measured: Baseline (Day 1) and Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start28 Jul 2025
- Primary completion3 Jun 2026
- Study completion3 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ceva W Pitoyo, Principal investigator, Ciptomangunkusumo hospital/Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892521
- Sponsor's protocol ID
- AMM-PULMONARY-EN-2025
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Randomized Controlled Trial of Pulmonary-Specific Enteral Nutrition on Neutrophil-to-Lymphocyte Ratio and Blood Lactate in Mechanically Ventilated Patients With Pneumonia
- ClinicalTrials.gov ID
- NCT07892521
- Acronym / sponsor ID
- AMM-PULMONARY-EN-2025
- Conditions
- Pneumonia
- Keywords
- Pulmonary-Specific Enteral Nutrition, Mechanical Ventilation, Neutrophil-to-Lymphocyte Ratio, Blood Lactate, Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 3 Jun 2026 (actual)
- Study completion
- 3 Jun 2026 (actual)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was a single-center, double-blind, parallel-group randomized controlled trial conducted in the Intensive Care Unit (ICU) and High Care Unit (HCU) of Cipto Mangunkusumo National Hospital, Jakarta, Indonesia, between January and December 2025.
The study evaluated whether pulmonary-specific enteral nutrition could influence systemic inflammatory and metabolic responses in critically ill adults with pneumonia requiring invasive mechanical ventilation. Eligible patients were adults aged 18-80 years with a diagnosis of pneumonia based on clinical, radiological, and laboratory findings, including community-acquired pneumonia, hospital-acquired pneumonia, and ventilator-associated pneumonia.
Participants were randomly assigned in a 1:1 ratio to receive pulmonary-specific enteral nutrition (Pulmosol®) or standard hospital enteral nutrition. Randomization was performed using a computer-generated block randomization sequence. Both formulas were provided in identical packaging to maintain blinding of investigators, healthcare providers, and outcome assessors.
Enteral nutrition was administered through a nasogastric or orogastric tube. Energy requirements were assessed using indirect calorimetry when available or estimated at approximately 25-30 kcal/kg/day. Nutritional delivery was initiated gradually, targeting approximately 70% of estimated energy requirements during the first three days and advancing toward the full caloric target thereafter. The protein intake target was approximately 1.2-1.5 g/kg/day.
The study assessed the neutrophil-to-lymphocyte ratio (NLR) as an inflammatory biomarker and blood lactate concentration as a metabolic biomarker. Measurements were performed on study days 1, 3, and 5. Changes in these parameters were evaluated within each treatment group and compared between the two groups.
The planned statistical approach included the Friedman test for within-group repeated measurements and the Mann-Whitney U test for between-group comparisons of changes in biomarker levels. Statistical significance was evaluated using a two-sided threshold of p < 0.05.
The study was approved by the Ethics Committee of the Faculty of Medicine, Universitas Indonesia-Cipto Mangunkusumo Hospital (KET-1383/UN2.F1/ETIK/PPM.00.02/2023). Written informed consent was obtained from participants or their legally authorized representatives before enrollment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary-Specific Enteral Nutrition | Experimental | Other: Pulmonary-Specific Enteral NutritionParticipants 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. |
| Standard Enteral Nutrition | Active comparator | Other: Standard Hospital Enteral NutritionParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Written informed consent provided by the participant or a legally authorized representative.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary-Specific Enteral NutritionAlso: PulmosolPulmonary-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. | Other | Pulmonary-Specific Enteral Nutrition |
| Standard Hospital Enteral NutritionStandard 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. | Other | Standard Enteral Nutrition |
Primary outcome
Change in Neutrophil-to-Lymphocyte Ratio (NLR) From Baseline to Day 5
Time frame: Baseline (Day 1) and 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.
1 secondary outcome
Change in Blood Lactate Levels From Baseline to Day 5
Time frame: Baseline (Day 1) and Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ceva W Pitoyo principal investigator
Ciptomangunkusumo hospital/Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary-Specific Enteral Nutrition and Standard Hospital Enteral Nutrition in people with Pneumonia, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neutrophil-to-Lymphocyte Ratio (NLR) From Baseline to Day 5 (time frame: Baseline (Day 1) and Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.