Cytomegalovirus Reactivation in ICU Patients Requiring Prolong Mechanical Ventilation

NCT06520605 | Recruiting

• 1 other identifier: 2024-122-DM-138
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation

Keywords

Critical Illnesses; Virus Activation; Cytomegalovirus

Outcome Measures

Primary Outcomes (2)

• The prevalence of cytomegalovirus reactivation in ICU patients requiring prolong mechanical ventilation

  Percentage of total included patients (CMV seropositive IgG) who had viral load \>1000/cc will be calculated.

  Till 4 weeks after the initiation of mechanical ventilation

• The correlation of CMV viral load with the severity of illness .

  Patients who had cytomegalovirus reactivation, the correlation will be explored between cytomegalovirus viral load with the severity of illness (total SOFA score).

  Till 3 weeks after the cytomegalovirus reactivation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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 screened for the possible inclusion.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

Study Sites (1)

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226014, India

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohan Gurjar, MD, PDCC

  Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohan Gurjar, MD, PDCC

CONTACT

+91-522-249-5403; m.gurjar@rediffmail.com

Kuldeep S Sindhlian, MD

CONTACT

kaviankuldeep@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: July 25, 2024
• Study Start: July 25, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

IN (1)