Status:
RECRUITING
Double-blind Pilot Study on the Effect of Anionic Exposome Enrichment (Biow) on Recovery and Sleep Quality in Postoperative Patients
Lead Sponsor:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Conditions:
Inflammatory Response After Surgery
Postoperative Recovery
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Airborne nanoparticle exposure is increasingly recognized as a significant contributor to oxidative stress, mitochondrial dysfunction, and low-grade systemic inflammation-factors that impair postopera...
Eligibility Criteria
Inclusion
- Adults aged ≥18 years, regardless of sex.
- Undergoing elective general surgery, preferably hepatobiliary procedures.
- Hospitalized for at least 4 days postoperatively in Unit 69 (HUFJD).
- Able to provide written informed consent.
- Considered to have medium or high risk of oxidative stress or mitochondrial dysfunction.
Exclusion
- Surgery within the previous 6 months, either outpatient or inpatient.
- Diagnosed psychiatric or neurological disorders, including epilepsy.
- Active progressive cancer or chronic inflammatory disease.
- Cognitive impairment or inability to comply with study procedures.
- BMI ≥30 kg/m² (obesity class I or higher).
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06968000
Start Date
March 1 2025
End Date
March 1 2027
Last Update
May 13 2025
Active Locations (1)
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1
Fundacion Instituto de Investigacion Sanitaria Fjd
Madrid, Madrid, Spain, 28040