Investigating Cytomegalovirus Reactivation in ICU Patients on Mechanical Ventilation
Cytomegalovirus Reactivation in Non-immunosuppressed Patients Requiring Prolong Mechanical Ventilation
Sanjay Gandhi Postgraduate Institute of Medical Sciences · NCT06520605
This study looks at whether critically ill patients on breathing machines get a virus called Cytomegalovirus (CMV) more often and how it might affect their recovery and survival.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sanjay Gandhi Postgraduate Institute of Medical Sciences (other gov) |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 1 site (Lucknow, Uttar Pradesh) |
| Trial ID | NCT06520605 on ClinicalTrials.gov |
What this trial studies
This observational study examines the reactivation of Cytomegalovirus (CMV) in critically ill patients requiring prolonged mechanical ventilation. It focuses on understanding how sepsis and its immunomodulatory effects may trigger CMV reactivation in patients who are otherwise considered immunocompetent. The study aims to document the incidence of CMV reactivation and its association with increased ICU stay and mortality rates. By analyzing the immune responses and viral loads in these patients, the research seeks to provide insights into the implications of CMV reactivation during critical illness.
Who should consider this trial
Good fit: Ideal candidates for this study are adult ICU patients requiring mechanical ventilation for at least 7 days and who are seropositive for CMV.
Not a fit: Patients under 18 years, those with known immune deficiencies, or those who have received antiviral treatment within the last week may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for critically ill patients, potentially reducing ICU stay and mortality associated with CMV reactivation.
How similar studies have performed: Previous studies have indicated a significant association between CMV reactivation and adverse outcomes in critically ill patients, suggesting that this approach has been explored with some success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All adult ICU patients requiring prolonged mechanically ventilation (at least 7 days of supportive ventilation) and the presence of CMV seropositivity (Anti CMV IgG antibodies) will be considered for inclusion Exclusion Criteria: * Age \<18 years * Use of anti viral agent within last 7 days * Duration of mechanical ventilation more than 14 days before the admission to our ICU * Known or suspected underlying immune deficiency (history of solid organ or stem cell transplantation, infection with human immunodeficiency virus, haematological malignancy, use of immunosuppressive medication (more than 0.1 mg /kg prednisone for \>3 months, more than 1 mg/kg/day prednisone for \>3 weeks or equivalent), chemotherapy/ radiotherapy in the year before ICU admission and any known humeral or cellular immune deficiency. * Pregnancy * Patient who do not consent for study
Where this trial is running
Lucknow, Uttar Pradesh
- Sanjay Gandhi Postgraduate Institute of Medical Sciences — Lucknow, Uttar Pradesh, India (RECRUITING)
Study contacts
- Principal investigator: Mohan Gurjar, MD, PDCC — Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
- Study coordinator: Mohan Gurjar, MD, PDCC
- Email: m.gurjar@rediffmail.com
- Phone: +91-522-249-5403
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mechanical Ventilation, Critical Illnesses, Virus Activation, Cytomegalovirus