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NCT07178483: NIVAR01
Evaluation of Physical Capacity and Energy Requirements in Patients With Hypoxemic Acute Respiratory Failure
trial in Acute Hypoxemic Respiratory Failure in 500 participants. Participants enrolled and being followed up; not accepting new ones.
1 March 2027
Quick facts
| Lead sponsor | Hospital Universitari de Bellvitge |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 1 March 2025 |
| Primary completion | 1 March 2027 |
| Estimated completion | 1 July 2027 |
| Sites | 1 location across Spain |
Conditions studied
- Acute Hypoxemic Respiratory Failure — all drugs for Acute Hypoxemic Respiratory Failure →
- Non Invasive Ventilation (NIV) — all drugs for Non Invasive Ventilation (NIV) →
- Bioimpedance Measurement Capacity — all drugs for Bioimpedance Measurement Capacity →
- Calorimetry, Indirect — all drugs for Calorimetry, Indirect →
Sponsor
Hospital Universitari de Bellvitge
Who can join
18 and older, any sex, with Acute Hypoxemic Respiratory Failure or Non Invasive Ventilation (NIV). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
NIVAR01 (Multimodal evaluation of physical capacity and energy requirements in patients with hypoxemic acute respiratory failure and community acquired pneumonia under non invasive ventilation support) aims to comprehensively assess energy requirements and physical capacity in patients with acute hypoxemic respiratory failure (AHRF) due to community-acquired pneumonia (CAP) undergoing non-invasive ventilation (NIV). Through a stepwise, multimodal approach integrating physiological measurements, imaging, and molecular biomarkers, the project seeks to identify patient subphenotypes that can guide targeted interventions, improve outcomes, and reduce the need for invasive mechanical ventilation. The project is structured in five progressive phases, each building on the findings of the previous one to refine and personalize care strategies. The first phase of the project aims to assess the correlation between BIA (bioelectrical impedance analysis) and IC (indirect calorimetry) in sedated patients, in oder to extrapolate this correlation in patients under NIV in the next phase. The second phase uses this correlation to validate the use of indirect calorimetry (IC) in patients under non-invasive ventilation (NIV) by comparing it with data obtained from patients under invasive mechanical ventilation, where IC is better established and technically more accurate. This comparative approach will serve to assess the reliability and feasibility of IC in NIV settings, incorporating correction factors for air leaks and comparing with BIA data, laying the groundwork for its integration with other physiological and biochemical measurements in subsequent phases. The third phase expands to a multimodal prospective observational cohort study integrating IC, BIA, ultrasound, biomarkers of mitochondrial and endothelial dysfunction, and innate immune system paralysis. These data will be used for patient phenotyping through advanced machine learning. The fourth and fifth phases will develop and test personalized nutritional and motor interventions (e.g., phrenic nerve stimulation, tailored physiotherapy) in clinical trials based on identified patient subtypes. Previous studies (Georges et al., Siirala et al., Singer 2024) have demonstrated the feasibility of using IC in NIV patients, although limited by methodological constraints. This project brings novelty by incorporating BIA-derived metabolic rate estimates and segmental analysis, offering new insights into body composition, fluid balance, and muscle integrity, including diaphragm function. Additionally, biomarkers such as cf-mtDNA, FGF-21, GDF-15, HSP60/10, and cytokine profiles (TNFα, IL-6, IL-10, CRP), as well as endothelial markers (e-Selectin, sICAM-1, vCAM-1, Syndecan-1), will be analyzed. Immune paralysis will be studied via monocyte HLA-DR expression and LPS-stimulated cytokine release. By leveraging multimodal data integration and gender-specific analysis, NIVAR 01 aims to optimize prediction of NIV failure beyond current tools such as the HACOR index and enable individualized patient management.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07178483
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07178483 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Universitari de Bellvitge
- Last refreshed: 16 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07178483.
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