SepsisPCO2NCT06256198
Role of PCO2 Gap as Predictor of Clinical Outcome in ICU Septic Patients
An observational study of Sepsis, run by Ain Shams University.
Trial summary
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, if not recognized early and managed promptly, it can lead to septic shock, multiple organ failure and death. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sepsis
- What is being tested?
- measurement of serum lactate and procalcitonin and PCO2 gap
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Jun 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted in ICU departments with sepsis
Who may be able to join
- Adult septic patients ≥ 21 years old
Who cannot join
- Patients with history of chronic obstructive pulmonary disease and bronchial asthma.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison Between PCO2 Gap, Lactate and Procalcitonin as Predictors of Clinical Outcome in ICU Septic Patients
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, if not recognized early and managed promptly, it can lead to septic shock, multiple organ failure and death. Sepsis is associated with high mortality, and the early recognition of the signs of tissue hypo perfusion is crucial in its management.
This prospective study was aimed to detect that PCO2 gap can be taken as a reliable prognostic tool in septic patients
Read the detailed description
In the community setting, sepsis often presents as the clinical deterioration of common and preventable infections. Sepsis also frequently results from infections acquired in health care settings, which are one of the most frequent adverse events during care delivery and affect hundreds of millions of patients worldwide every year The venous-to-arterial carbon dioxide difference (Pv-aCO2) can indicate the adequacy of microvascular blood flow in the early phases of resuscitation in sepsis. Hence, other resuscitation goals, such as PCO2 gap, have been suggested, due to their ability to predict adverse clinical outcomes and simplicity in patients achieving normal oxygen-derived parameters during the early phases of resuscitation in septic shock.
Blood lactate level is also useful in evaluating sepsis. Serum lactate is a good indicator of the presence of hypoxic tissue during septic shock, since its production takes place during Anerobic metabolism.
Procalcitonin (PCT) is the precursor of calcitonin, and higher levels are associated with the development of sepsis. Com¬monly, there is an elevation of PCT levels 4 h after the on¬set of symptoms, peaking between 8 h and 24 h.
- Conditions
- Sepsis
- Being tested
- measurement of serum lactate and procalcitonin and PCO2 gap
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of serum lactate and procalcitonin and PCO2 gapOther
measurement of serum lactate, procalcitonin and PCO2 gap
| Study group | Role | What they receive |
|---|---|---|
| Group S | survivors Receives: Other: measurement of serum lactate and procalcitonin and PCO2 gap | |
| Group M | non survivors Receives: Other: measurement of serum lactate and procalcitonin and PCO2 gap |
What is being measured
The primary outcome is the main question the study is designed to answer.
prediction of clinical outcome in ICU septic patients
PCO2 gap mmHg will be measured on admission and after 48 hours
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed wagih Ezzat deusouky, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256198
- Sponsor's protocol ID
- MS 719/2022
- Acronym
- PCO2
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between PCO2 Gap, Lactate and Procalcitonin as Predictors of Clinical Outcome in ICU Septic Patients
- ClinicalTrials.gov ID
- NCT06256198
- Acronym / sponsor ID
- PCO2 / MS 719/2022
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 13 Feb 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.
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, if not recognized early and managed promptly, it can lead to septic shock, multiple organ failure and death. Sepsis is associated with high mortality, and the early recognition of the signs of tissue hypo perfusion is crucial in its management.
This prospective study was aimed to detect that PCO2 gap can be taken as a reliable prognostic tool in septic patients
Detailed description
In the community setting, sepsis often presents as the clinical deterioration of common and preventable infections. Sepsis also frequently results from infections acquired in health care settings, which are one of the most frequent adverse events during care delivery and affect hundreds of millions of patients worldwide every year The venous-to-arterial carbon dioxide difference (Pv-aCO2) can indicate the adequacy of microvascular blood flow in the early phases of resuscitation in sepsis. Hence, other resuscitation goals, such as PCO2 gap, have been suggested, due to their ability to predict adverse clinical outcomes and simplicity in patients achieving normal oxygen-derived parameters during the early phases of resuscitation in septic shock.
Blood lactate level is also useful in evaluating sepsis. Serum lactate is a good indicator of the presence of hypoxic tissue during septic shock, since its production takes place during Anerobic metabolism.
Procalcitonin (PCT) is the precursor of calcitonin, and higher levels are associated with the development of sepsis. Com¬monly, there is an elevation of PCT levels 4 h after the on¬set of symptoms, peaking between 8 h and 24 h.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | – | Other: measurement of serum lactate and procalcitonin and PCO2 gapsurvivors |
| Group M | – | Other: measurement of serum lactate and procalcitonin and PCO2 gapnon survivors |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted in ICU departments with sepsis
Key inclusion criteria (1 listed)
- Adult septic patients ≥ 21 years old
Key exclusion criteria (1 listed)
- Patients with history of chronic obstructive pulmonary disease and bronchial asthma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of serum lactate and procalcitonin and PCO2 gapmeasurement of serum lactate, procalcitonin and PCO2 gap | Other | Group M, Group S |
Primary outcome
prediction of clinical outcome in ICU septic patients
Time frame: 48 hours
PCO2 gap mmHg will be measured on admission and after 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Ain Shams University.
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 1 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: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed El-Dolah, lecturer of Anesthesia (+20111113077, a_wagih82@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prediction of clinical outcome in ICU septic patients (time frame: 48 hours). 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 13 Feb 2024.