Red Cell Distribution Width and Lactate Albumin Ratio as Prognostic Markers for Mortality in Sepsis and Septic Shock

NCT05921825 | Unknown

• 1 other identifier: 34640/4/12
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to find the utility of red cell distribution width and lactate/albumin ratio as prognostic markers in sepsis and septic shock patients.

Conditions

Morality; Sepsis; Septic Shock

Outcome Measures

Primary Outcomes (1)

• The prediction of mortality

  The diagnostic accuracy for prediction of 28th day mortality by Red cell distribution Width and lactate albumin ratio.

  28 days

Secondary Outcomes (2)

• Length of intensive care stay

  28 days or till discharge from intensive care.

• Extent of organ dysfunctions in patients with severe sepsis and septic shock

  28 days

Study Arms (2)

Non survivors group

At 28 day, patients were divided into Non survivors group and Survivors group.

Diagnostic Test: Red cell distribution width; Diagnostic Test: lactate albumin ratio measurement

Survivors group

At 28 day, patients were divided into Non survivors group and Survivors group.

Diagnostic Test: Red cell distribution width; Diagnostic Test: lactate albumin ratio measurement

Interventions

Red cell distribution width DIAGNOSTIC_TEST

Blood will be drawn from the peripheral vein, arterial or a central catheter. This procedure will be done at diagnosis, 3 ,7, 14 and 21 days of sepsis

Non survivors group; Survivors group

lactate albumin ratio measurement DIAGNOSTIC_TEST

Blood will be drawn from the peripheral vein, arterial or a central catheter. This procedure will be done at diagnosis, 3 ,7, 14 and 21 days of sepsis

Non survivors group; Survivors group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients of both sex with age between (18:60) years old admitted to surgical intensive care unit suffering from sepsis or septic shock will be enrolled in the study after fulfillments of inclusion and exclusion criteria.

You may qualify if:

• Age from 18 to 60 years old.
• Clinical criteria of sepsis
• Or clinical criteria of septic shock including sepsis with persisting hypotension requiring vasopressors to maintain mean arterial pressure \> 65 mmHg and having a serum lactate level \> 2 mmol/L despite adequate volume resuscitation.

You may not qualify if:

• No informed consent.
• Patient with incomplete information and data.
• The patient who received blood transfusion within 90 days before emergency admission.
• The patients who are known to have long-term conditions causing anemia like sickle cell anemia, thalassemia, iron deficiency anemia.
• Malignancy and chemotherapy during the previous 90 days.
• Patients with either hepatic dysfunction, renal failure, having any disease in which albumin should be supplemented as liver cirrhosis with ascites, nephrotic syndrome and burns.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Elgharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Erythrocyte Indices

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Shimaa S Awd, MBBCh

CONTACT

+20 101 011 6084; shimaa_saad@med.tanta.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: June 27, 2023
• Study Start: July 1, 2023
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From one year after study completion
• Access Criteria: The data will be available upon reasonable request from the corresponding author

Locations

EG (1)