Cardiogenic ShockNCT07773597
Prognostic Value Enhancement Of Sequential Organ Failure Assessment )SOFA( Score by Neutrophil-Lymphocyte Ratio and Red Cell Distribution Width in Cardiogenic Shock Patients.
An observational study of Cardiogenic Shock, run by Sohag University at 1 site in Egypt.
Trial summary
Prognostic Value Enhancement Of Sequential Organ Failure Assessment )SOFA( Score by Neutrophil-Lymphocyte Ratio and Red Cell Distribution Width in Cardiogenic Shock Patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2026to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: A total of 150 patients will be recruited. The sample size was determined based on the ability to evaluate the prognostic value of neutrophil-lymphocyte ratio and red cell distribution width in patients with cardiogenic shock. Based on previous studies, the expected in-hospital mortality among cardiogenic shock patients is approximately 40-50%. With a confidence level of 95% and a statistical power of 80%, a minimum sample size of 90 patients was required. To account for possible missing data or incomplete records, the sample size was increased by 10%, resulting in a final sample size of 150 patients.
Who may be able to join
- Adult patients aged ≥18 years
- Diagnosis of cardiogenic shock based on:
- Systolic blood pressure < 90 mmHg for ≥30 minutes or need for vasopressor support Signs of tissue hypoperfusion (cold extremities, oliguria, altered mental status, elevated lactate) Evidence of cardiac dysfunction Cardiogenic shock secondary to acute coronary syndrome or other cardiac causes Availability of complete blood count on admission
Who cannot join
- Septic, hypovolemic, or obstructive shock Active infection or chronic inflammatory disease Hematological disorders affecting leukocytes or red blood cells Malignancy Chronic liver disease Recent blood transfusion Patients on immunosuppressive or steroid therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Medicine , Sohag University
Sohag
dr marwa diab mohamed, +0201128618557, marwa.diab@med.sohag.edu.eg
About this study
Prognostic Value Enhancement Of Sequential Organ Failure Assessment )SOFA( Score by Neutrophil-Lymphocyte Ratio and Red Cell Distribution Width in Cardiogenic Shock Patients.
- Conditions
- Cardiogenic Shock
- Keywords
- Neutrophil-Lymphocyte Ratio and Red Cell Distribution Width in Cardiogenic Shock Patients.
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cardiogenic shock patients | cardiogenic shock patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Higher NLR and RDW values who died With Cardiogenic Shock
Occurrence of death from any cause during hospitalization, assessed in relation to baseline neutrophil-to-lymphocyte ratio (NLR) and red cell distribution width (RDW).
Measured: through study completion, an average 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Diab Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773597
- Sponsor's protocol ID
- Soh-Med-26-7-8MS
- Status last verified
- Jul 2026
- First submitted
- 8 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value Enhancement Of Sequential Organ Failure Assessment )SOFA( Score by Neutrophil-Lymphocyte Ratio and Red Cell Distribution Width in Cardiogenic Shock Patients.
- ClinicalTrials.gov ID
- NCT07773597
- Acronym / sponsor ID
- Soh-Med-26-7-8MS
- Conditions
- Cardiogenic Shock
- Keywords
- Neutrophil-Lymphocyte Ratio and Red Cell Distribution Width in Cardiogenic Shock Patients.
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 19 Aug 2026 (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.
Prognostic Value Enhancement Of Sequential Organ Failure Assessment )SOFA( Score by Neutrophil-Lymphocyte Ratio and Red Cell Distribution Width in Cardiogenic Shock Patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiogenic shock patients | – | –cardiogenic shock patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 150 patients will be recruited. The sample size was determined based on the ability to evaluate the prognostic value of neutrophil-lymphocyte ratio and red cell distribution width in patients with cardiogenic shock. Based on previous studies, the expected in-hospital mortality among cardiogenic shock patients is approximately 40-50%. With a confidence level of 95% and a statistical power of 80%, a minimum sample size of 90 patients was required. To account for possible missing data or incomplete records, the sample size was increased by 10%, resulting in a final sample size of 150 patients.
Key inclusion criteria (3 listed)
- Adult patients aged ≥18 years
- Systolic blood pressure < 90 mmHg for ≥30 minutes or need for vasopressor support Signs of tissue hypoperfusion (cold extremities, oliguria, altered mental status, elevated lactate) Evidence of cardiac dysfunction Cardiogenic shock secondary to acute coronary syndrome or other cardiac causes Availability of complete blood count on admission
Key exclusion criteria (1 listed)
- Septic, hypovolemic, or obstructive shock Active infection or chronic inflammatory disease Hematological disorders affecting leukocytes or red blood cells Malignancy Chronic liver disease Recent blood transfusion Patients on immunosuppressive or steroid therapy
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
Number of patients with Higher NLR and RDW values who died With Cardiogenic Shock
Time frame: through study completion, an average 6 months.
Occurrence of death from any cause during hospitalization, assessed in relation to baseline neutrophil-to-lymphocyte ratio (NLR) and red cell distribution width (RDW).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 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.
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 Cardiogenic Shock, run by Sohag 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 3 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: opening soon, as of the sponsor's last update on 19 Aug 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact dr marwa diab mohamed (+0201128618557, marwa.diab@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Higher NLR and RDW values who died With Cardiogenic Shock (time frame: through study completion, an average 6 months.). 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 19 Aug 2026.