NCT06520605 Cytomegalovirus Reactivation in ICU Patients Requiring Prolong Mechanical Ventilation
| NCT ID | NCT06520605 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| Condition | Mechanical Ventilation |
| Study Type | OBSERVATIONAL |
| Enrollment | 125 participants |
| Start Date | 2024-07-25 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 125 participants in total. It began in 2024-07-25 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cytomegalovirus (CMV) is a latent infection virus that is widespread in the population. CMV may reactivate under certain circumstances, and its hazardous nature has been proven, especially in immunosuppressed patients. However in recent years, some studies have found that CMV reactivation also exists in apparently immunocompetent patients during their critical illness. In these non-immunosuppressed patients, the presence of sepsis and its immunomodulatory effects may lead to reactivation of dormant viral infections. Studies found the incidence of CMV reactivation in up to one-fourth to half of these non-immunosuppressed patients during their critical illness. These studies also documented significantly higher length of ICU stay and mortality in critically ill patients with CMV reactivation. CMV reactivation has also been studied in specific critically ill cohorts, exhibiting there impact on mortality. David S Y Yong et al studied the effect of CMV reactivation on mortality in immunocompetent acute respiratory distress syndrome (ARDS) patients. In a recent study, it was found that among cohort of non-immunosuppressed patients with acute respiratory distress syndrome (ARDS), CMV reactivation occurred in 27 % of patients which was associated with overall increased ICU mortality. In another study among septic shock cohort (329 patients), herpesvirus reactivations were documented in 68% patients without prior immunodeficiency and concluded that reactivations could be independently associated with mortality. However currently, no study is available investigating the CMV reactivation and it's kinetics during critical illness in non immunocompetent patients requiring prolonged mechanical ventilation. In this planned observational study, we aim to find out the prevalence of Cytomegalovirus (CMV) reactivation, viral load and it's association with the severity of illness in non immunosuppressed ICU patients requiring prolong mechanical ventilation.
Eligibility 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
Contact & Investigator
Mohan Gurjar, MD, PDCC
PRINCIPAL INVESTIGATOR
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
Frequently Asked Questions
Who can join the NCT06520605 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Mechanical Ventilation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06520605 currently recruiting?
Yes, NCT06520605 is actively recruiting participants. Contact the research team at m.gurjar@rediffmail.com for enrollment information.
Where is the NCT06520605 trial being conducted?
This trial is being conducted at Lucknow, India.
Who is sponsoring the NCT06520605 clinical trial?
NCT06520605 is sponsored by Sanjay Gandhi Postgraduate Institute of Medical Sciences. The principal investigator is Mohan Gurjar, MD, PDCC at Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS). The trial plans to enroll 125 participants.