Mechanical VentilationNCT06520605
Cytomegalovirus Reactivation in ICU Patients Requiring Prolong Mechanical Ventilation
An observational study of Mechanical Ventilation, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mechanical Ventilation
- How many people
- 117 participants
- Where
- 1 siteIndia
- Study dates
- 25 Jul 2024to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, 226014
About this study
Official title: Cytomegalovirus Reactivation in Non-immunosuppressed Patients Requiring Prolong Mechanical Ventilation
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.
Read the detailed description
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, several studies have found that CMV reactivation also exists in immunocompetent patients with a critical illness. Among those patients, the incidence of CMV reactivation, which is more than 30%, is associated with increased duration of hospital stay, and higher mortality.
Traditionally, critically ill patients have been considered immunocompetent but the presence of sepsis and its immunomodulatory effects may lead to reactivation of dormant viral infections. Sepsis due to its immunomodulatory effects may lead to reactivation of CMV due to the release of pro-inflammatory cytokines such as TNF-alpha and IL-1beta which has the ability to activate several transcription factors contributing in the CMV reactivation. Clari et al showed that CMV infection in critically ill patients was consistently associated with undetectable IFN-γ T cell responses within the first 2 days of admission to the ICU, and that viral load was inversely related to IFN-γ T cell responses. Similar results were also found by Venet et al that septic patients display immune system paralysis, reduced Th1 cell function, increased IL-10 production (anti-inflammatory), global lymphopenia affecting natural killer cells (NK) quantitatively and qualitatively related to their interferon production.
Studies have documented significantly higher organ failure rates and mortality in critically ill patients with CMV reactivation. Phillips Lachance et al performed a systematic review to investigate the association between CMV reactivation and clinical outcomes in immunocompetent critically ill patients. In this review, twenty-two studies were included. CMV reactivation was associated with increased ICU mortality, overall mortality, duration of mechanical ventilation, nosocomial infections, ICU length of stay. 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. Of 399 ARDS patients, 68 % were CMV seropositive and reactivation occurred in 27 % of them 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 currently available investigating the CMV reactivation and it's kinetics during critical illness in non-immunosuppressed patients requiring prolonged mechanical ventilation. In this planned observational study, the investigators aimed to find out the prevalence of CMV reactivation, viral load and it's association with the severity of illness in non-immunosuppressed ICU patients requiring prolong mechanical ventilation.
All adult ICU patients requiring prolong mechanical ventilation will be considered for inclusion and will be screened for the presence of Anti CMV IgG antibodies in blood. If patient is IgG seropositive and meets inclusion/ exclusion criteria, then they will be included in study and will be followed up for CMV reactivation during their ICU stay (on weekly basis till maximum 28-days after the initiation of mechanical ventilation). In patients who had CMV reactivation, viral load kinetics will be further followed up on weekly basis for the next 3 weeks or ICU discharged (whichever comes first). Blood samples will be collected in all; while tracheal aspirate sample will be collected in whom who had an artificial airway.
- Conditions
- Mechanical Ventilation
- Keywords
- Critical Illnesses, Virus Activation, Cytomegalovirus
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Till 3 weeks after the cytomegalovirus reactivation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start25 Jul 2024
- Primary completion2 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohan Gurjar, Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Investigators
- Mohan Gurjar, MD, PDCC, Principal investigator, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520605
- Sponsor's protocol ID
- 2024-122-DM-138
- Status last verified
- Oct 2026
- First submitted
- 20 Jul 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytomegalovirus Reactivation in Non-immunosuppressed Patients Requiring Prolong Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT06520605
- Acronym / sponsor ID
- 2024-122-DM-138
- Conditions
- Mechanical Ventilation
- Keywords
- Critical Illnesses, Virus Activation, Cytomegalovirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical SciencesOther government
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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, several studies have found that CMV reactivation also exists in immunocompetent patients with a critical illness. Among those patients, the incidence of CMV reactivation, which is more than 30%, is associated with increased duration of hospital stay, and higher mortality.
Traditionally, critically ill patients have been considered immunocompetent but the presence of sepsis and its immunomodulatory effects may lead to reactivation of dormant viral infections. Sepsis due to its immunomodulatory effects may lead to reactivation of CMV due to the release of pro-inflammatory cytokines such as TNF-alpha and IL-1beta which has the ability to activate several transcription factors contributing in the CMV reactivation. Clari et al showed that CMV infection in critically ill patients was consistently associated with undetectable IFN-γ T cell responses within the first 2 days of admission to the ICU, and that viral load was inversely related to IFN-γ T cell responses. Similar results were also found by Venet et al that septic patients display immune system paralysis, reduced Th1 cell function, increased IL-10 production (anti-inflammatory), global lymphopenia affecting natural killer cells (NK) quantitatively and qualitatively related to their interferon production.
Studies have documented significantly higher organ failure rates and mortality in critically ill patients with CMV reactivation. Phillips Lachance et al performed a systematic review to investigate the association between CMV reactivation and clinical outcomes in immunocompetent critically ill patients. In this review, twenty-two studies were included. CMV reactivation was associated with increased ICU mortality, overall mortality, duration of mechanical ventilation, nosocomial infections, ICU length of stay. 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. Of 399 ARDS patients, 68 % were CMV seropositive and reactivation occurred in 27 % of them 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 currently available investigating the CMV reactivation and it's kinetics during critical illness in non-immunosuppressed patients requiring prolonged mechanical ventilation. In this planned observational study, the investigators aimed to find out the prevalence of CMV reactivation, viral load and it's association with the severity of illness in non-immunosuppressed ICU patients requiring prolong mechanical ventilation.
All adult ICU patients requiring prolong mechanical ventilation will be considered for inclusion and will be screened for the presence of Anti CMV IgG antibodies in blood. If patient is IgG seropositive and meets inclusion/ exclusion criteria, then they will be included in study and will be followed up for CMV reactivation during their ICU stay (on weekly basis till maximum 28-days after the initiation of mechanical ventilation). In patients who had CMV reactivation, viral load kinetics will be further followed up on weekly basis for the next 3 weeks or ICU discharged (whichever comes first). Blood samples will be collected in all; while tracheal aspirate sample will be collected in whom who had an artificial airway.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of cytomegalovirus reactivation in ICU patients requiring prolong mechanical ventilation
Time frame: Till 4 weeks after the initiation of mechanical ventilation
Percentage of total included patients (CMV seropositive IgG) who had viral load >1000/cc will be calculated.
The correlation of CMV viral load with the severity of illness .
Time frame: Till 3 weeks after the cytomegalovirus reactivation
Patients who had cytomegalovirus reactivation, the correlation will be explored between cytomegalovirus viral load with the severity of illness (total SOFA score).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohan Gurjar, MD, PDCC principal investigator
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of cytomegalovirus reactivation in ICU patients requiring prolong mechanical ventilation (time frame: Till 4 weeks after the initiation of mechanical ventilation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.