Septic ShockNCT05289388
a Novel Index for Tissue Perfusion in Predicting Outcome in Patients With Septic Shock
An observational study of Septic Shock, run by Cairo University at 1 site in Egypt.
Trial summary
Septic shock is a life-threatening condition with mortality rate of up to -40%. Septic shock is catheterized by altered microcirculation that leads to tissue hypoperfusion and ultimately multi-organ dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Lactate/CRT index
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2022to Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients with clinically suspected septic shock according to the latest definition of septic shock (sepsis-3) "hypotension in a patient with sepsis requiring vasopressor therapy to maintain mean arterial pressure above 65 mmHg despite adequate fluid resuscitation in addition to elevated serum lactate level (above 2 mmol/L)"
Who may be able to join
- Patients with clinically suspected septic shock, older than 18 years old
Who cannot join
- Patients less than 18 years.
- patients with evident blood loss.
- patients with metastatic cancer.
- Patients with Child B or C liver cirrhosis
- patients with estimated glomerulo filtartion rate less than 30 ml/min/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Reliability of a Novel Index for Tissue Perfusion in Predicting Outcome in Patients With Septic Shock: a Prospective Observational Study.
Septic shock is a life-threatening condition with mortality rate of up to -40%. Septic shock is catheterized by altered microcirculation that leads to tissue hypoperfusion and ultimately multi-organ dysfunction. Hence, maintenance of adequate tissue perfusion is the mainstay of resuscitation of patients with septic shock.
Serum lactate is still considered the gold standard for evaluation of tissue perfusion. Thus, according to the latest definition, elevated serum lactate, as an indicator of tissue hypo-perfusion, is required for diagnosis of septic shock. However, lactate level change in response to resuscitation is slow even in survivors.
Read more
Capillary refill time (CRT) is a simple method for assessing peripheral perfusion. Monitoring CRT was found to be a good tool for guiding resuscitation and delayed CRT showed good ability in predicting mortality in patients with septic shock.
To the best of our knowledge, there is no previous report assessing the reliability of an index that include both serum lactate and CRT (lactate/CRT index) in predicting mortality in patients with septic shock.
We hypothesize that the lactate/CRT index would have good accuracy in predicting mortality in patient with septic shock.
Read the detailed description
All patients will be monitored with; non-invasive and invasive arterial blood pressure, five-lead electrocardiography (ECG), hourly urinary output, and central venous pressure (CVP). Management of the patients will be done according to the latest surviving sepsis campaign guidelines in 2016. APACHE II score will be calculated on the time of admission using MDCalc ©.
Arterial blood gases, including serum lactate (blood gas analysis device GEM premier 300, Instrumentation Laboratory, Bedford, MA, USA), will be obtained at the time of intensive care unit admission, 6 and 12 hours after admission. Capillary refill time will be measured by applying enough pressure to cause skin blanching to the ventral surface of the distal phalanx of right index finger and the pressure will be then maintained for 10 seconds. The time for return of the normal skin color will be registered with a stopwatch. CRT will be recoded at the same time point as the blood sample.
The change in serum lactate (∆ Lactate), and CRT (∆ CRT) will be calculated as the difference between each two-consecutive measurement. Lactate/CRT index will be calculated as the product of multiplying the CRT and serum lactate.
- Conditions
- Septic Shock
- Being tested
- Lactate/CRT index
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactate/CRT indexDiagnostic test
index will be calculated as the product of multiplying the CRT and serum lactate
What is being measured
The primary outcome is the main question the study is designed to answer.
the ability of Lactate/CRT index in predicting patient's outcome
multiplying the CRT and serum lactate
Measured: 6 hour after admission
Secondary outcomes (5)
ability of Lactate/CRT index in predicting patient's outcome
multiplying the CRT and serum lactate
Measured: 12 hours after admission
ability of Lactate in predicting patient's outcome
mg/dl
Measured: 6 and 12 hours after admission
ability of CRT in predicting patient's outcome
Capillary refill time will be measured by applying enough pressure to cause skin blanching to the ventral surface of the distal phalanx of right index finger and the pressure will be then maintained for 10 seconds. The time for return of the normal skin color will be registered with a stopwatch
Measured: 6 and 12 hours after admission
change in serum lactate
the difference between each two-consecutive measurement
Measured: WITHIN 1 HOUR, 6 and 12 hours after admission
change in CRT
the difference between each two-consecutive measurement
Measured: WITHIN 1 HOUR, 6 and 12 hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- ahmed hasanin, Principal investigator, Cairo University Kasr Alainy Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289388
- Sponsor's protocol ID
- N182022
- Status last verified
- Mar 2022
- First submitted
- 13 Mar 2022
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the protocol and data supporting this study will be available from the PI upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability of a Novel Index for Tissue Perfusion in Predicting Outcome in Patients With Septic Shock: a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT05289388
- Acronym / sponsor ID
- N182022
- Conditions
- Septic Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 21 Mar 2022 (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.
Septic shock is a life-threatening condition with mortality rate of up to -40%. Septic shock is catheterized by altered microcirculation that leads to tissue hypoperfusion and ultimately multi-organ dysfunction. Hence, maintenance of adequate tissue perfusion is the mainstay of resuscitation of patients with septic shock.
Serum lactate is still considered the gold standard for evaluation of tissue perfusion. Thus, according to the latest definition, elevated serum lactate, as an indicator of tissue hypo-perfusion, is required for diagnosis of septic shock. However, lactate level change in response to resuscitation is slow even in survivors.
Capillary refill time (CRT) is a simple method for assessing peripheral perfusion. Monitoring CRT was found to be a good tool for guiding resuscitation and delayed CRT showed good ability in predicting mortality in patients with septic shock.
To the best of our knowledge, there is no previous report assessing the reliability of an index that include both serum lactate and CRT (lactate/CRT index) in predicting mortality in patients with septic shock.
We hypothesize that the lactate/CRT index would have good accuracy in predicting mortality in patient with septic shock.
Detailed description
All patients will be monitored with; non-invasive and invasive arterial blood pressure, five-lead electrocardiography (ECG), hourly urinary output, and central venous pressure (CVP). Management of the patients will be done according to the latest surviving sepsis campaign guidelines in 2016. APACHE II score will be calculated on the time of admission using MDCalc ©.
Arterial blood gases, including serum lactate (blood gas analysis device GEM premier 300, Instrumentation Laboratory, Bedford, MA, USA), will be obtained at the time of intensive care unit admission, 6 and 12 hours after admission. Capillary refill time will be measured by applying enough pressure to cause skin blanching to the ventral surface of the distal phalanx of right index finger and the pressure will be then maintained for 10 seconds. The time for return of the normal skin color will be registered with a stopwatch. CRT will be recoded at the same time point as the blood sample.
The change in serum lactate (∆ Lactate), and CRT (∆ CRT) will be calculated as the difference between each two-consecutive measurement. Lactate/CRT index will be calculated as the product of multiplying the CRT and serum lactate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients with clinically suspected septic shock according to the latest definition of septic shock (sepsis-3) "hypotension in a patient with sepsis requiring vasopressor therapy to maintain mean arterial pressure above 65 mmHg despite adequate fluid resuscitation in addition to elevated serum lactate level (above 2 mmol/L)"
Key inclusion criteria (1 listed)
- Patients with clinically suspected septic shock, older than 18 years old
Key exclusion criteria (5 listed)
- Patients less than 18 years.
- patients with evident blood loss.
- patients with metastatic cancer.
- Patients with Child B or C liver cirrhosis
- patients with estimated glomerulo filtartion rate less than 30 ml/min/m2
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 |
|---|---|---|
| Lactate/CRT indexindex will be calculated as the product of multiplying the CRT and serum lactate | Diagnostic test | – |
Primary outcome
the ability of Lactate/CRT index in predicting patient's outcome
Time frame: 6 hour after admission
multiplying the CRT and serum lactate
5 secondary outcomes
ability of Lactate/CRT index in predicting patient's outcome
Time frame: 12 hours after admission
ability of Lactate in predicting patient's outcome
Time frame: 6 and 12 hours after admission
ability of CRT in predicting patient's outcome
Time frame: 6 and 12 hours after admission
change in serum lactate
Time frame: WITHIN 1 HOUR, 6 and 12 hours after admission
change in CRT
Time frame: WITHIN 1 HOUR, 6 and 12 hours after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No. the protocol and data supporting this study will be available from the PI upon reasonable request
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
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Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
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Sepsis
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 hasanin principal investigator
Cairo University Kasr Alainy Faculty of Medicine
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 Septic Shock, run by Cairo 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 5 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 21 Mar 2022. 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 Maha Mostafa (01000365115, maha.mostafa@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the ability of Lactate/CRT index in predicting patient's outcome (time frame: 6 hour after admission). 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 21 Mar 2022.