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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis; Septic Shock; Morality
• Intervention / Treatment: Diagnostic test: Red cell distribution width; Diagnostic test: lactate albumin ratio measurement

Detailed Description

Several indicators are being used to predict the prognosis of sepsis. Commonly used prognostic indicators include Acute Physiological and chronic health evaluation II (APACHE II), Sequential Organ Failure Assessment (SOFA), Mortality in Emergency Department Score (MEDS), New York Sepsis severity score.

Red cell distribution Width and lactate albumin ratio are being investigated for there prognostic value in septic patients.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Shimaa S Awd, MBBCh; Phone Number: +20 101 011 6084; Email: shimaa_saad@med.tanta.edu.eg

Study Locations

• Egypt
  • Elgharbia
    • Tanta, Elgharbia, Egypt, 31527
      • Tanta University Hospitals
      • Contact: Shimaa S Awd, MSc; Phone Number: +20 101 011 6084; Email: shimaa_saad@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

1. Age from 18 to 60 years old.
2. Clinical criteria of sepsis
3. 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.

Exclusion Criteria:

1. No informed consent.
2. Patient with incomplete information and data.
3. The patient who received blood transfusion within 90 days before emergency admission.
4. The patients who are known to have long-term conditions causing anemia like sickle cell anemia, thalassemia, iron deficiency anemia.
5. Malignancy and chemotherapy during the previous 90 days.
6. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non survivors group; At 28 day, patients were divided into Non survivors group and Survivors group.	Diagnostic test: Red cell distribution width; 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; Diagnostic test: lactate albumin ratio measurement; 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
Survivors group; At 28 day, patients were divided into Non survivors group and Survivors group.	Diagnostic test: Red cell distribution width; 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; Diagnostic test: lactate albumin ratio measurement; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of intensive care stay	Length of intensive care stay from admission till discharge either to the ward or mortality.	28 days or till discharge from intensive care.
Extent of organ dysfunctions in patients with severe sepsis and septic shock	Organ dysfunction can be confirmed by acute change in sepsis-related organ failure assessment (SOFA).	28 days

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): January 30, 2024
• Study Completion (Estimated): January 30, 2024

Study Registration Dates

• First Submitted: June 18, 2023
• First Submitted That Met QC Criteria: June 18, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 18, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Shock, Septic; Shock
• Other Study ID Numbers: 34640/4/12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request from the corresponding author from one year after study completion
• IPD Sharing Time Frame: From one year after study completion
• IPD Sharing Access Criteria: The data will be available upon reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No