NCT07773597

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Aug 2026Jan 2027

First Submitted

Initial submission to the registry

August 8, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

August 30, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

August 19, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

August 8, 2026

Last Update Submit

August 14, 2026

Conditions

Keywords

Neutrophil-Lymphocyte Ratio and Red Cell Distribution Width in Cardiogenic Shock Patients.

Outcome Measures

Primary Outcomes (1)

  • 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).

    through study completion, an average 6 months.

Study Arms (1)

cardiogenic shock patients

cardiogenic shock patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine , Sohag University

Sohag, Egypt

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Central Study Contacts

dr marwa diab mohamed

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician in Internal Medicine

Study Record Dates

First Submitted

August 8, 2026

First Posted

August 19, 2026

Study Start

August 30, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

August 19, 2026

Record last verified: 2026-07

Locations