Septic ShockNCT05088109
Shock Indices Use for Early Mortality From Septic Shock
An observational study of Septic Shock and Morality, run by Cairo University at 1 site in Egypt.
Trial summary
Background and Rationale: Sepsis is a universal healthcare problem with a high incidence and mortality. Improvement in early sepsis recognition and management has reduced the 28 day- and in-hospital mortality in the last two decades. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Morality
- What is being tested?
- early mortality prediction using septic shock indices
- How many people
- 43 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Oct 2021to Feb 2023
- How long will I take part?
- 3 Days
- 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: Patients with septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock, which states septic shock as the combination of suspected infection accompanying life-threatening organ dysfunction, the requirement of vasopressor therapy to elevate MAP ≥65 mmHg and lactate > 2 mmol/L despite adequate fluid resuscitation.
Who may be able to join
- adult patients (>18 years) with septic shock
Who cannot join
- Age < 18 years
- arrythmia
- History of ischemic heart disease
- cardiomyopathy
- pregnant women
- liver cirrhosis (Child B or C)
- renal impairment
- shock other than septic shock.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University hospitals
Cairo, Manial, 12511
Ayman Hussam, M.D., 01004389020, Ahhussam@yahoo.com
About this study
Official title: The Use of Shock Indices in Adults as Bedside Clinical Predictors for Early Death From Sepsis. A Prospective Observational Study
Background and Rationale:
Sepsis is a universal healthcare problem with a high incidence and mortality. Improvement in early sepsis recognition and management has reduced the 28 day- and in-hospital mortality in the last two decades. Mortality rates from sepsis ranges from 20% to 30% of which one-third occurs within 3 days of ICU admission.
Read more
Identifying patients with sepsis or septic shock who are at increased risk of early death can direct the priority of care for these patients and assist in predicting who is most likely to benefit from higher levels of care. In addition, this can encourage for direct future clinical trials to investigate new therapeutic interventions. Despite the large body of research on biomarkers (e.g. Serum lactate, interlukins) and clinical prediction tools (e.g. mSOFA score, APACHE II) for rapid risk stratification and in-hospital mortality of septic patients, the early identification of patients at increased risk for clinical deterioration remains challenging and the data on predictors of early death in septic patients remains deficient.
Persistently low MAP or DAP have been related to worse outcomes in septic shock, this was aggravated by the new-onset prolonged sinus tachycardia which occur as a result of sympathetic activity. This associated tachycardia has been linked to increased major cardiovascular events, prolonged length of stay and higher mortality rates The recent study by Ospina-Tascón et al. presented a novel index, the "diastolic shock index" (DSI), defined as the ratio of heart rate (HR) and diastolic arterial pressure (DAP). They studied the diastolic shock index relation to clinical outcomes in patients with septic shock. In their study, this index represented a very early identifier of patients at high risk of death within 28 days and 90 days after admission, while isolated DAP or HR values did not clearly identify such risk.
A few previous studies focused on the comparison between shock indices for prediction of sepsis outcomes and their results had a preference for DSI and MSI over SI.In this study we defined early mortality as that will occur within 3 days from admission or start of septic shock. This definition was based on previous works performed in patients with septic shock, for whom trends in organ failures during the first 3 days in the ICU were found accurate predictors of outcome .
However, almost no study focused on the ability of the diastolic shock index to predict early ICU mortality from sepsis within 72 hours from admission. So, this study aims to fill this gap in the literature.
Objectives : to investigate the ability of the diastolic shock index to predict early ICU mortality from sepsis within 72 hours from admission
- Conditions
- Septic Shock, Morality
- Being tested
- early mortality prediction using septic shock indices
- Keywords
- sepsis, early mortality, shock indices, diastolic shock index
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early mortality prediction using septic shock indicesDiagnostic test
The Shock Index (SI) is the ratio of pulse rate to systolic blood pressure calculated by dividing pulse rate (beat/min) by systolic blood pressure (mm Hg). The adjusted shock index (ASI) is SI calculated after adjusting the heart rate according to body temperature that 10 beats will be added to the heart rate for every 1.0 °C rise in the body temperature above 37.0 °C. The modified shock index (MSI) is a ratio of heart rate to mean blood pressure (MAP). The DSI is a ratio of heart rate to diastolic blood pressure (DAP).
| Study group | Role | What they receive |
|---|---|---|
| SI | adult patients with septic shock will be enrolled,At the time of admission (before the start of vasopressors), age of patients, source of sepsis, baseline systolic (SBP), diastolic (DBP), mean blood pressure (MAP), heart rate (HR), shock index (SI), adjusted shock index (ASI), modified shock index (MSI), diastolic shock index (DSI), baseline lactate, ABG, capillary refill time and body temperature will be recorded. Subsequent recordings will be at 0 (before starting vasopressors), 1, 2, 4, 8, and 12, 24, 48, 72 hours for all parameters except for lactate and ABG will be every 12 hours. SOFA scores, APACHE II, GCS, Charlson Comorbidity Index, will be recorded at admission; and mean total vasopressor dose, urine output will be recorded daily. Cause of death will be documented. All readings will continue for 72 after admission. Receives: Diagnostic Test: early mortality prediction using septic shock indices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early ICU mortality from septic shock
The ability of DSI to predict early ICU mortality
Measured: 3 days from admission by septic shock
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start24 Oct 2021
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 43 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Abdullah Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088109
- Sponsor's protocol ID
- N-27-2021/RS
- Status last verified
- Jan 2023
- First submitted
- 8 Oct 2021
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not to share
Publications
Ospina-Tascon GA, Teboul JL, Hernandez G, Alvarez I, Sanchez-Ortiz AI, Calderon-Tapia LE, Manzano-Nunez R, Quinones E, Madrinan-Navia HJ, Ruiz JE, Aldana JL, Bakker J. Diastolic shock index and clinical outcomes in patients with septic shock. Ann Intensive Care. 2020 Apr 16;10(1):41. doi: 10.1186/s13613-020-00658-8.
PubMed 32296976Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
PubMed 11445675
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Shock Indices in Adults as Bedside Clinical Predictors for Early Death From Sepsis. A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05088109
- Acronym / sponsor ID
- N-27-2021/RS
- Conditions
- Septic Shock, Morality
- Keywords
- sepsis, early mortality, shock indices, diastolic shock index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 Oct 2021 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 21 Oct 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.
Background and Rationale:
Sepsis is a universal healthcare problem with a high incidence and mortality. Improvement in early sepsis recognition and management has reduced the 28 day- and in-hospital mortality in the last two decades. Mortality rates from sepsis ranges from 20% to 30% of which one-third occurs within 3 days of ICU admission.
Identifying patients with sepsis or septic shock who are at increased risk of early death can direct the priority of care for these patients and assist in predicting who is most likely to benefit from higher levels of care. In addition, this can encourage for direct future clinical trials to investigate new therapeutic interventions. Despite the large body of research on biomarkers (e.g. Serum lactate, interlukins) and clinical prediction tools (e.g. mSOFA score, APACHE II) for rapid risk stratification and in-hospital mortality of septic patients, the early identification of patients at increased risk for clinical deterioration remains challenging and the data on predictors of early death in septic patients remains deficient.
Persistently low MAP or DAP have been related to worse outcomes in septic shock, this was aggravated by the new-onset prolonged sinus tachycardia which occur as a result of sympathetic activity. This associated tachycardia has been linked to increased major cardiovascular events, prolonged length of stay and higher mortality rates The recent study by Ospina-Tascón et al. presented a novel index, the "diastolic shock index" (DSI), defined as the ratio of heart rate (HR) and diastolic arterial pressure (DAP). They studied the diastolic shock index relation to clinical outcomes in patients with septic shock. In their study, this index represented a very early identifier of patients at high risk of death within 28 days and 90 days after admission, while isolated DAP or HR values did not clearly identify such risk.
A few previous studies focused on the comparison between shock indices for prediction of sepsis outcomes and their results had a preference for DSI and MSI over SI.In this study we defined early mortality as that will occur within 3 days from admission or start of septic shock. This definition was based on previous works performed in patients with septic shock, for whom trends in organ failures during the first 3 days in the ICU were found accurate predictors of outcome .
However, almost no study focused on the ability of the diastolic shock index to predict early ICU mortality from sepsis within 72 hours from admission. So, this study aims to fill this gap in the literature.
Objectives : to investigate the ability of the diastolic shock index to predict early ICU mortality from sepsis within 72 hours from admission
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SI | – | Diagnostic Test: early mortality prediction using septic shock indicesadult patients with septic shock will be enrolled,At the time of admission (before the start of vasopressors), age of patients, source of sepsis, baseline systolic (SBP), diastolic (DBP), mean blood pressure (MAP), heart rate (HR), shock index (SI), adjusted shock index (ASI), modified shock index (MSI), diastolic shock index (DSI), baseline lactate, ABG, capillary refill time and body temperature will be recorded. Subsequent recordings will be at 0 (before starting vasopressors), 1, 2, 4, 8, and 12, 24, 48, 72 hours for all parameters except for lactate and ABG will be every 12 hours. SOFA scores, APACHE II, GCS, Charlson Comorbidity Index, will be recorded at admission; and mean total vasopressor dose, urine output will be recorded daily. Cause of death will be documented. All readings will continue for 72 after admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock, which states septic shock as the combination of suspected infection accompanying life-threatening organ dysfunction, the requirement of vasopressor therapy to elevate MAP ≥65 mmHg and lactate > 2 mmol/L despite adequate fluid resuscitation.
Key inclusion criteria (1 listed)
- adult patients (>18 years) with septic shock
Key exclusion criteria (8 listed)
- Age < 18 years
- arrythmia
- History of ischemic heart disease
- cardiomyopathy
- pregnant women
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 |
|---|---|---|
| early mortality prediction using septic shock indicesThe Shock Index (SI) is the ratio of pulse rate to systolic blood pressure calculated by dividing pulse rate (beat/min) by systolic blood pressure (mm Hg). The adjusted shock index (ASI) is SI calculated after adjusting the heart rate according to body temperature that 10 beats will be added to the heart rate for every 1.0 °C rise in the body temperature above 37.0 °C. The modified shock index (MSI) is a ratio of heart rate to mean blood pressure (MAP). The DSI is a ratio of heart rate to diastolic blood pressure (DAP). | Diagnostic test | SI |
Primary outcome
Early ICU mortality from septic shock
Time frame: 3 days from admission by septic shock
The ability of DSI to predict early ICU mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Background: PubMed 32296976Ospina-Tascon GA, Teboul JL, Hernandez G, Alvarez I, Sanchez-Ortiz AI, Calderon-Tapia LE, Manzano-Nunez R, Quinones E, Madrinan-Navia HJ, Ruiz JE, Aldana JL, Bakker J. Diastolic shock index and clinical outcomes in patients with septic shock. Ann Intensive Care. 2020 Apr 16;10(1):41. doi: 10.1186/s13613-020-00658-8.
- Results publication: PubMed 11445675Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
- Individual participant dataSharing planned: No. not to share
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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.
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 and Morality, 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 8 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 11 Jan 2023. 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 Sherif Abdullah, M.D. (01002013497 ext. 02, dr.sherif213@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early ICU mortality from septic shock (time frame: 3 days from admission by septic shock). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05088109, which also lists 2 linked publications.
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 11 Jan 2023.