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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05921825
• Other study ID #: 34640/4/12
• Status: Not yet recruiting
• Start date: July 1, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: June 2023
• Source: Tanta University
• Contact: Shimaa S Awd, MBBCh
• Phone: +20 101 011 6084
• Email: shimaa_saad[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Morality
• Sepsis
• Septic Shock
• Shock
• Shock, Septic
• Toxemia

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	Elgharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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