Prognostic Value Enhancement Of Sequential Organ Failure Assessment )SOFA( Score by Neutrophil-Lymphocyte Ratio and Red Cell Distribution Width in Cardiogenic Shock Patients.

August 14, 2026 updated by: Marwa Diab Mohamed, Sohag University
Prognostic Value Enhancement Of Sequential Organ Failure Assessment )SOFA( Score by Neutrophil-Lymphocyte Ratio and Red Cell Distribution Width in Cardiogenic Shock Patients.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
cardiogenic shock patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
through study completion, an average 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 30, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

August 8, 2026

First Submitted That Met QC Criteria

August 14, 2026

First Posted (Actual)

August 19, 2026

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-26-7-8MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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