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

Not yet recruiting

• Conditions: Septic Shock; Sepsis; Morality
• Interventions: Diagnostic Test: Red cell distribution width; Diagnostic Test: lactate albumin ratio measurement

• Registration Number: NCT05921825
• Lead Sponsor: Tanta University

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.

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 Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-18
• Study First Submitted QC: 2023-06-18
• Last Update Submitted: 2023-06-18
• Study First Posted: 2023-06-27
• Last Update Posted: 2023-06-27
• Study Start: 2023-07-01
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Survivors group	Red cell distribution width	At 28 day, patients were divided into Non survivors group and Survivors group.
Non survivors group	lactate albumin ratio measurement	At 28 day, patients were divided into Non survivors group and Survivors group.
Survivors group	lactate albumin ratio measurement	At 28 day, patients were divided into Non survivors group and Survivors group.
Non survivors group	Red cell distribution width	At 28 day, patients were divided into Non survivors group and Survivors group.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Elgharbia, Egypt