Sepsis SyndromeNCT05049941
Blood Gases Versus Lactate Clearance as an Indicator of Initial Resuscitation in Septic Patients: Comparative Study
An observational study of Sepsis Syndrome, run by Minia University at 1 site in Egypt.
Trial summary
This perspective blind randomized single center study was designed to assess central venous and arterial gases level including P(v-a)CO2/C(a-v)O2 ratio and P(v-a)CO2 difference against lactate clearance as an indicator of initial resuscitation in septic patients in intensive care unit and to evaluate the success of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sepsis Syndrome
- What is being tested?
- lactat and blood gases
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2021to 15 Dec 2021
- 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 65 years
- All sexes
- Adult, Older adult
Study population: 120 adult critically ill patients admitted to the ICU in Minia University Hospital. Patients Ages was ≥ 18 and ≤ 65 years including both sexs, resuscitation started after fulfilling the diagnostic criteria of sepsis issued by Surviving Sepsis Campaign 2016
Who may be able to join
- adult critically ill patients admitted to the ICU in Minia University Hospital. Patients Ages was ≥ 18 and ≤ 65 years including both sexs, resuscitation started after fulfilling the diagnostic criteria of sepsis issued by Surviving Sepsis Campaign 2016
Who cannot join
- We excluded Patients with chronic organ failure (Cardiovascular, Respiratory, Liver, Neurological and Renal.)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Hassanein
Minya, 11116
ahmed hassanein, 01006946879, ahmedhassanein10@yahoo.com
rehab mohamed, 01004407515, rehabmohamed820@gmail.com
About this study
- This perspective blind randomized single center study was designed to assess central venous and arterial gases level including P(v-a)CO2/C(a-v)O2 ratio and P(v-a)CO2 difference against lactate clearance as an indicator of initial resuscitation in septic patients in intensive care unit and to evaluate the success of early resuscitation protocol .this continuation of our previous work we compared the ratio of P(v-a)CO2/C(a-v)O2 ratio against lactate clearance(8). Mortality in the ICU in the study groups will be recorded
Read the detailed description
On ICU admission, Criteria of Systemic Inflammatory Response Criteria (SIRS) were evaluated including: abnormal white blood cell count >12,000/ μL or <4000/ μL, heart rate >90/min, respiratory rate >20/min or PaCO2 < 32 mmHg or abnormal body temperature >38.3 °C (100.4 °F) or <36 °C (96.8 °F). The quick Sequential Organ Failure assessment (qSOFA) score (10) measured at the bedside : altered level of consciousness (Glasgow Coma Scale score ≤ 13), Systolic blood pressure < 90 mmHg and respiratory rate ≥ 22 rpm. The Acute Physiology and Chronic Health Evaluation (APACHE II) score were collected (Knaus et al.,1985). Patients monitoring of heart rate, pulse oximetry, invasive arterial blood pressure for measurement of MAP, core temperature (UltraviewSL2700; Spacelaps, USA). and urine output. Laboratory investigations includes: complete blood count, C-reactive protein, liver and renal functions, coagulation profile, blood glucose, sodium and potassium level. All patients had jugular central venous catheter was inserted under ultrasound guidance, and the position confirmed by chest radiograph, then central venous pressure (CVP) was measured before starting the initial resuscitation (T0) ansd 8 hours after resuscitation (T8). From CVP line, blood sample analyzed by (SIEMENS RAPIDPoint® 500 blood gas machine). The following measurements were recorded at (T0) and at (T8): Central venous oxygen saturation (ScvO2), Central venous oxygen tension (Pvo2) and Central venous carbon dioxide tension (Pvco2). The central venous oxygen content (Cvo2) Cvo2 = (1.34 × Svo2 × Hb) + (0.003 × Pvo2) Radial arterial canula was inserted under ultrasound guidance to all patients and arterial blood gases (ABG) was analyzed at (T0) and (T8) to measure: arterial oxygen tension (Pao2), arterial oxygen content (Cao2), arterial carbon dioxide tension (Paco2), arterial oxygen saturation (Sao2.) and lactate level Cao2 = (1.34 × Sao2 × Hb) + (0.003 × Pao2) Resuscitation Patients were randomly assigned (by computer generated sequence) into three groups each consists of 40 patients: Group (1): veno-arterial carbon dioxide tension / arteriovenous oxygen content P(v-a)CO2/C(a-v)O2 ratio group; Group (2): Lactate clearance (LC) group; Lactate level was measured then LC rate was calculated by the equation [(lactate(T0)- lactate(T8))/lactate(T0)] × 100%.
Group (3):
veno-arterial carbon dioxide tension group; P(v-a)co2 difference Measurements were obtained at T0 (before the start of resuscitation) and at T8 (after 8 hours of the start of resuscitation), the three groups received the same initial resuscitation protocol according to Surviving Sepsis Campaign (9), the appropriate specimens were taken for aerobic and anaerobic culture, empirical broad-spectrum antibiotics was given, source of infection was controlled with removal of any old intravascular lines which may be the source of sepsis.
The early goals of resuscitation were to achieve the following: CVP of 8-12 cmH2O, MAP > 65 mm Hg, a urine output >0.5 mL/kg and Scvo2 of 70% or more, we started with 30 ml/kg crystalloids in the first 3 hours, then we guided by hemodynamic status, if not achieved, we were targeted by titrating vasopressors until MAP > 65 mmHg by using either norepinephrine (0.25 mcg /kg/min increasing every 15 min) or dobutamine (2.5 mcg/min every 15 min increased). The patients connected to mechanical ventilation if needed with appropriate settings, with minimal dose of sedation, blood glucose controlled and anticoagulant and Proton pump inhibitors were administrated as a prophylaxis, early enteral nutrition was initiated, if there was no contraindications Measured data
In group (1) we prepared this measures at T0 and T8:
- The arteriovenous oxygen content difference (C(a-v)O2) C(a-v)O2 = Cao2 - Cvo2
- The venoarterial CO2 tension difference (P(v-a)CO2) P(v-a)CO2 = Pvco2 - Paco2
- P(v-a)CO2/C(a-v)O2 ratio
- (Pvco2 - Paco2)/(Cao2 - Cvo2)
- Conditions
- Sepsis Syndrome
- Being tested
- lactat and blood gases
- Medical subject headings
- Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lactat and blood gasesDiagnostic test
observational
| Study group | Role | What they receive |
|---|---|---|
| group1 | Group (1): veno-arterial carbon dioxide tension / arteriovenous oxygen content P(v-a)CO2/C(a-v)O2 ratio group. Receives: Diagnostic Test: lactat and blood gases | |
| group 2 | Group (2): Lactate clearance (LC) group; Lactate level was measured then LC rate was calculated by the equation [(lactate(T0)- lactate(T8))/lactate(T0)] × 100%. Receives: Diagnostic Test: lactat and blood gases | |
| group 3 | Group (3):
veno-arterial carbon dioxide tension group; P(v-a)co2 difference Receives: Diagnostic Test: lactat and blood gases |
What is being measured
The primary outcome is the main question the study is designed to answer.
in septic patients in intensive care unit and to evaluate the success of early resuscitation protocol
success of early resuscitation
Measured: 3-4 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start15 Aug 2021
- Primary completion15 Nov 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis SyndromeStudies of the same condition, open and under way.
- More trials run by Minia 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hassanein Mohamed, Minia University
- Investigators
- ahmed hassanein, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049941
- Sponsor's protocol ID
- 6382021
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Gases Versus Lactate Clearance as an Indicator of Initial Resuscitation in Septic Patients: Comparative Study
- ClinicalTrials.gov ID
- NCT05049941
- Acronym / sponsor ID
- 6382021
- Conditions
- Sepsis Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 15 Nov 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 20 Sep 2021 (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.
- This perspective blind randomized single center study was designed to assess central venous and arterial gases level including P(v-a)CO2/C(a-v)O2 ratio and P(v-a)CO2 difference against lactate clearance as an indicator of initial resuscitation in septic patients in intensive care unit and to evaluate the success of early resuscitation protocol .this continuation of our previous work we compared the ratio of P(v-a)CO2/C(a-v)O2 ratio against lactate clearance(8). Mortality in the ICU in the study groups will be recorded
Detailed description
On ICU admission, Criteria of Systemic Inflammatory Response Criteria (SIRS) were evaluated including: abnormal white blood cell count >12,000/ μL or <4000/ μL, heart rate >90/min, respiratory rate >20/min or PaCO2 < 32 mmHg or abnormal body temperature >38.3 °C (100.4 °F) or <36 °C (96.8 °F). The quick Sequential Organ Failure assessment (qSOFA) score (10) measured at the bedside : altered level of consciousness (Glasgow Coma Scale score ≤ 13), Systolic blood pressure < 90 mmHg and respiratory rate ≥ 22 rpm. The Acute Physiology and Chronic Health Evaluation (APACHE II) score were collected (Knaus et al.,1985). Patients monitoring of heart rate, pulse oximetry, invasive arterial blood pressure for measurement of MAP, core temperature (UltraviewSL2700; Spacelaps, USA). and urine output. Laboratory investigations includes: complete blood count, C-reactive protein, liver and renal functions, coagulation profile, blood glucose, sodium and potassium level. All patients had jugular central venous catheter was inserted under ultrasound guidance, and the position confirmed by chest radiograph, then central venous pressure (CVP) was measured before starting the initial resuscitation (T0) ansd 8 hours after resuscitation (T8). From CVP line, blood sample analyzed by (SIEMENS RAPIDPoint® 500 blood gas machine). The following measurements were recorded at (T0) and at (T8): Central venous oxygen saturation (ScvO2), Central venous oxygen tension (Pvo2) and Central venous carbon dioxide tension (Pvco2). The central venous oxygen content (Cvo2) Cvo2 = (1.34 × Svo2 × Hb) + (0.003 × Pvo2) Radial arterial canula was inserted under ultrasound guidance to all patients and arterial blood gases (ABG) was analyzed at (T0) and (T8) to measure: arterial oxygen tension (Pao2), arterial oxygen content (Cao2), arterial carbon dioxide tension (Paco2), arterial oxygen saturation (Sao2.) and lactate level Cao2 = (1.34 × Sao2 × Hb) + (0.003 × Pao2) Resuscitation Patients were randomly assigned (by computer generated sequence) into three groups each consists of 40 patients: Group (1): veno-arterial carbon dioxide tension / arteriovenous oxygen content P(v-a)CO2/C(a-v)O2 ratio group; Group (2): Lactate clearance (LC) group; Lactate level was measured then LC rate was calculated by the equation [(lactate(T0)- lactate(T8))/lactate(T0)] × 100%.
Group (3):
veno-arterial carbon dioxide tension group; P(v-a)co2 difference Measurements were obtained at T0 (before the start of resuscitation) and at T8 (after 8 hours of the start of resuscitation), the three groups received the same initial resuscitation protocol according to Surviving Sepsis Campaign (9), the appropriate specimens were taken for aerobic and anaerobic culture, empirical broad-spectrum antibiotics was given, source of infection was controlled with removal of any old intravascular lines which may be the source of sepsis.
The early goals of resuscitation were to achieve the following: CVP of 8-12 cmH2O, MAP > 65 mm Hg, a urine output >0.5 mL/kg and Scvo2 of 70% or more, we started with 30 ml/kg crystalloids in the first 3 hours, then we guided by hemodynamic status, if not achieved, we were targeted by titrating vasopressors until MAP > 65 mmHg by using either norepinephrine (0.25 mcg /kg/min increasing every 15 min) or dobutamine (2.5 mcg/min every 15 min increased). The patients connected to mechanical ventilation if needed with appropriate settings, with minimal dose of sedation, blood glucose controlled and anticoagulant and Proton pump inhibitors were administrated as a prophylaxis, early enteral nutrition was initiated, if there was no contraindications Measured data
In group (1) we prepared this measures at T0 and T8:
- The arteriovenous oxygen content difference (C(a-v)O2) C(a-v)O2 = Cao2 - Cvo2
- The venoarterial CO2 tension difference (P(v-a)CO2) P(v-a)CO2 = Pvco2 - Paco2
- P(v-a)CO2/C(a-v)O2 ratio
- (Pvco2 - Paco2)/(Cao2 - Cvo2)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group1 | – | Diagnostic Test: lactat and blood gasesGroup (1): veno-arterial carbon dioxide tension / arteriovenous oxygen content P(v-a)CO2/C(a-v)O2 ratio group. |
| group 2 | – | Diagnostic Test: lactat and blood gasesGroup (2): Lactate clearance (LC) group; Lactate level was measured then LC rate was calculated by the equation [(lactate(T0)- lactate(T8))/lactate(T0)] × 100%. |
| group 3 | – | Diagnostic Test: lactat and blood gasesGroup (3): veno-arterial carbon dioxide tension group; P(v-a)co2 difference |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 120 adult critically ill patients admitted to the ICU in Minia University Hospital. Patients Ages was ≥ 18 and ≤ 65 years including both sexs, resuscitation started after fulfilling the diagnostic criteria of sepsis issued by Surviving Sepsis Campaign 2016
Key inclusion criteria (1 listed)
- adult critically ill patients admitted to the ICU in Minia University Hospital. Patients Ages was ≥ 18 and ≤ 65 years including both sexs, resuscitation started after fulfilling the diagnostic criteria of sepsis issued by Surviving Sepsis Campaign 2016
Key exclusion criteria (1 listed)
- We excluded Patients with chronic organ failure (Cardiovascular, Respiratory, Liver, Neurological and Renal.)
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 |
|---|---|---|
| lactat and blood gasesobservational | Diagnostic test | group 2, group 3, group1 |
Primary outcome
in septic patients in intensive care unit and to evaluate the success of early resuscitation protocol
Time frame: 3-4 monthes
success of early resuscitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
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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.
ahmed hassanein, MD principal investigator
Minia University
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 Sepsis Syndrome, run by Minia University at 1 site in Egypt.
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 20 Sep 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmed hassanein, MD (01006946879, ahmedhassanein10@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in septic patients in intensive care unit and to evaluate the success of early resuscitation protocol (time frame: 3-4 monthes). 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 Sep 2021.