MoralityNCT05921825
Red Cell Distribution Width and Lactate Albumin Ratio as Prognostic Markers for Mortality in Sepsis and Septic Shock
An observational study of Morality and Sepsis, run by Tanta University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morality, Sepsis, Septic Shock
- What is being tested?
- Red cell distribution width and lactate albumin ratio measurement
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 30 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Age from 18 to 60 years old.
- Clinical criteria of sepsis
- 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.
Who cannot join
- No informed consent.
- Patient with incomplete information and data.
- The patient who received blood transfusion within 90 days before emergency admission.
- The patients who are known to have long-term conditions causing anemia like sickle cell anemia, thalassemia, iron deficiency anemia.
- Malignancy and chemotherapy during the previous 90 days.
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Tanta University Hospitals
Tanta, Elgharbia, 31527
Shimaa S Awd, MSc, +20 101 011 6084, shimaa_saad@med.tanta.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Morality, Sepsis, Septic Shock
- Being tested
- Red cell distribution width, lactate albumin ratio measurement
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red cell distribution widthDiagnostic test
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 measurementDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Non survivors group | At 28 day, patients were divided into Non survivors group and Survivors group. Receives: Diagnostic Test: Red cell distribution width; Diagnostic Test: lactate albumin ratio measurement | |
| Survivors group | At 28 day, patients were divided into Non survivors group and Survivors group. Receives: Diagnostic Test: Red cell distribution width; Diagnostic Test: lactate albumin ratio measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prediction of mortality
The diagnostic accuracy for prediction of 28th day mortality by Red cell distribution Width and lactate albumin ratio.
Measured: 28 days
Secondary outcomes (2)
Length of intensive care stay
Length of intensive care stay from admission till discharge either to the ward or mortality.
Measured: 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).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoralityStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Saad Mohamed Awd, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921825
- Sponsor's protocol ID
- 34640/4/12
- Status last verified
- Jun 2023
- First submitted
- 18 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the corresponding author from one year after study completion
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Cell Distribution Width and Lactate Albumin Ratio as Prognostic Markers for Mortality in Sepsis and Septic Shock Patients
- ClinicalTrials.gov ID
- NCT05921825
- Acronym / sponsor ID
- 34640/4/12
- Conditions
- Morality, Sepsis, Septic Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non survivors group | – | Diagnostic Test: Red cell distribution width, Diagnostic Test: lactate albumin ratio measurementAt 28 day, patients were divided into Non survivors group and Survivors group. |
| Survivors group | – | Diagnostic Test: Red cell distribution width, Diagnostic Test: lactate albumin ratio measurementAt 28 day, patients were divided into Non survivors group and Survivors group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Age from 18 to 60 years old.
- Clinical criteria of sepsis
- 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.
Key exclusion criteria (6 listed)
- No informed consent.
- Patient with incomplete information and data.
- The patient who received blood transfusion within 90 days before emergency admission.
- The patients who are known to have long-term conditions causing anemia like sickle cell anemia, thalassemia, iron deficiency anemia.
- Malignancy and chemotherapy during the previous 90 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red cell distribution widthBlood 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 | Non survivors group, Survivors group |
| lactate albumin ratio measurementBlood 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 | Non survivors group, Survivors group |
Primary outcome
The prediction of mortality
Time frame: 28 days
The diagnostic accuracy for prediction of 28th day mortality by Red cell distribution Width and lactate albumin ratio.
2 secondary outcomes
Length of intensive care stay
Time frame: 28 days or till discharge from intensive care.
Extent of organ dysfunctions in patients with severe sepsis and septic shock
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the corresponding author from one year after study completion
Related trials for Morality
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
Not yet recruitingObservational study
Medical,Nursing Record,PE, Blood Test and Radiological Examination ,Morality and Mobility of Multiple Trauma Patient
Trauma Centers/Statistics & Numerical Data, Trauma Blunt
RecruitingPhase 3
Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and Moral Injury
PTSD, Post Traumatic Stress Disorder, Moral Injury
RecruitingObservational study
Collecting the Results of Multiple Trauma Patients and Find the Correlation of Morality and Mobility
Multiple Trauma/Injuries
Not yet recruiting
Mobile-Based Resilience Intervention for Moral Injury, Compassion Fatigue, and Distress in ICU Nurses
Moral Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morality and Sepsis, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shimaa S Awd, MBBCh (+20 101 011 6084, shimaa_saad@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prediction of mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.