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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05921825
Other study ID # 34640/4/12
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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