NCT07353138

Brief Summary

This prospective, observational study investigates the relationship between early oxygen exposure and oxidative stress in adult intensive care unit patients with sepsis or septic shock. Fraction of inspired oxygen (FiO₂) administered during the first 24 hours of ICU admission will be recorded and analyzed in relation to changes in the uric acid/albumin ratio (UAR), a biomarker reflecting oxidative burden and inflammation. Serum uric acid and albumin levels will be measured at baseline and at 24 hours, and the percentage change in UAR will be calculated. Secondary analyses will examine associations between UAR changes, oxygenation indices, and 28-day mortality. The study aims to determine whether higher FiO₂ exposure is associated with increased oxidative stress and to evaluate the potential role of UAR as a clinically accessible marker of oxygen-related oxidative injury in septic ICU patients.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 7, 2026

Last Update Submit

January 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Early Postoperative Pain Severity

    early postoperative pain severity, as measured using the Visual Analog Scale (VAS). 0: no pain, 10 worst pain

    Within the first 60 minutes after admission to the Post-Anesthesia Care Unit (PACU).

Interventions

Not applicable. This is a prospective observational study. No intervention or alteration to standard treatment protocols will be performed. Clinical and laboratory data obtained during routine care, including preoperative hemogram parameters and early postoperative pain scores, will be recorded and analyzed without influencing patient management.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult patients aged 18-65 years who undergo elective septorhinoplasty under general anesthesia. All participants are managed according to standard clinical practice and are admitted to the Post-Anesthesia Care Unit (PACU) postoperatively, where early pain assessments and routine clinical monitoring are performed. Eligible patients have a complete preoperative hemogram obtained within 30 days prior to surgery and comprehensive postoperative records, including pain scores and vital signs. Patients with conditions or treatments that could significantly affect inflammatory markers or pain perception are excluded to ensure a homogeneous study population

You may qualify if:

  • Adult patients aged 18-65 years
  • Patients undergoing elective septorhinoplasty
  • Surgery performed under general anesthesia
  • Complete recording of early postoperative VAS pain scores, Aldrete scores, NUDES scores, and vital signs in the Post-Anesthesia Care Unit (PACU)
  • Preoperative complete blood count (hemogram) performed within 30 days prior to surgery
  • Clinical records and hospital information system data that are complete, accessible, and adequate for analysis

You may not qualify if:

  • Patients undergoing emergency surgery
  • Septorhinoplasty combined with additional major surgical procedures (e.g., advanced ENT or maxillofacial surgery)
  • Presence of known hematological disease, active infection, immunosuppressive therapy, or advanced liver or renal failure
  • Chronic opioid use or regular analgesic medication use in the preoperative period
  • History of significant clinical events between the preoperative hemogram and surgery that could alter inflammatory status (e.g., infection, hospitalization, additional surgery)
  • Incomplete or missing data regarding preoperative hemogram parameters or PACU pain scores

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Sachidananda R, Malipatil A, Joshi V, Hosamani A, Haranagatti A, Kurugodiyavar MD. Relationship between neutrophil-lymphocyte ratio and postoperative pain in cesarean section patients done under subarachnoid block: A prospective observational study. J Anaesthesiol Clin Pharmacol. 2025 Jul-Sep;41(3):464-469. doi: 10.4103/joacp.joacp_213_24. Epub 2024 Dec 16.

    PMID: 40635819BACKGROUND
  • Yildiz Altun A, Demirel I, Bolat E, Ozcan S, Altun S, Aksu A, Bestas A. The Relationship Between the Preoperative Neutrophil-to-Lymphocyte Ratio and Postoperative Nausea and Vomiting in Patients Undergoing Septorhinoplasty Surgery. Aesthetic Plast Surg. 2019 Jun;43(3):861-865. doi: 10.1007/s00266-019-01325-5. Epub 2019 Feb 14.

    PMID: 30767038BACKGROUND

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assos.Prof.

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 20, 2026

Study Start

January 1, 2026

Primary Completion

March 15, 2026

Study Completion

March 31, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01