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

Sponsor
Tanta University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05921825
Collaborator
(none)
70
1
7
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Red Cell Distribution Width and Lactate Albumin Ratio as Prognostic Markers for Mortality in Sepsis and Septic Shock Patients
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jan 30, 2024
Anticipated Study Completion Date :
Jan 30, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tanta University Hospitals Tanta Elgharbia Egypt 31527

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shimaa Saad Mohamed Awd, Assistant lecturer, Tanta University
ClinicalTrials.gov Identifier:
NCT05921825
Other Study ID Numbers:
  • 34640/4/12
First Posted:
Jun 27, 2023
Last Update Posted:
Jun 27, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2023