Burn InjuriesNCT07761845
Red Cell Distribution Width/Albumin Ratio as a Predictive Tool for Mortality of Patients With Burn Injuries
An observational study of Burn Injuries, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the prognostic utility of the red cell distribution width/albumin ratio (RAR), measured within 24 hours of hospital admission, in predicting 30-day mortality among patients with burn injuries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Injuries
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 1 Apr 2027
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with acute thermal injuries will be screened based on inclusion/exclusion criteria. After consent, Patients' characteristics (age, sex, weight), clinical parameters (Total burn surface area, Abbreviated burn severity index), and comorbidities will be recorded.
Who may be able to join
- Age > 18 years.
- Both sexes.
- Patients with burn injuries (%TBSA >20%).
- Availability of complete laboratory data (RDW, albumin) on admission.
- Admission to ICU within 24 hours of burn injury.
Who cannot join
- Age <18 years.
- Patients with chronic hematologic disease.
- Pre-existing liver disease.
- Nephrotic syndrome.
- patients on chemotherapy.
- Patients with incomplete or missing lab records.
- Pregnant females.
- Patient or guardian refusal.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ahlam M abdelnaby. study principal investigator, MBBCH, MSc . contact
Sara H Saleh, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university
Cairo, Cairo Governorate, 11111
About this study
Official title: Measurement of Red Cell Distribution Width/Albumin Ratio as a Predictive Tool for 30-day Mortality of Patients With Burn Injuries
The aim of this study is to evaluate the prognostic utility of the red cell distribution width/albumin ratio (RAR), measured within 24 hours of hospital admission, in predicting 30-day mortality among patients with burn injuries.
Read the detailed description
The aim of this study is to evaluate the prognostic utility of the red cell distribution width/albumin ratio (RAR), measured within 24 hours of hospital admission, in predicting 30-day mortality among patients with burn injuries.
Patients presenting with acute thermal injuries will be screened based on inclusion/exclusion criteria.
After consent, patients' characteristics (age, sex, weight), clinical parameters (total burn surface area, Abbreviated Burn Severity Index), and comorbidities will be recorded.
- Emergency Department (ED) management (Arrival and Initial Stabilization)
- Primary survey (ATLS principles): Immediate stabilization of Airway, Breathing, Circulation, Disability, Exposure (ABCDE).
- Urinary catheter insertion to monitor urine output for proper resuscitation.
- TBSA will be estimated using the Rule of Nines
- All patients will be treated during the first 24 hours after burn injury guided by the Parkland Formula.
- In-Hospital Resuscitation (0-72 h)
- Hemodynamic monitoring: ECG, pulse oximetry, respiratory rate, temperature, non-invasive blood pressure, arterial line if unstable, and central venous pressure.
- Transition to Day 2 (24-48 h post-burn): Continue Lactated Ringer's and consider colloid therapy (5% albumin or plasma) after 24 h to maintain oncotic pressure and reduce crystalloid load.
- Fluid adjustments according to urine output, mean arterial pressure with target MAP (≥65 mmHg), lactate clearance, and base deficit. Laboratory and calculation: On admission to ED, an arterial blood gas (ABG) sample will be collected to calculate base deficit (BD) and lactate level. Simultaneously, venous blood will be drawn for C-reactive protein (CRP) and serum albumin, CBC, serum urea, creatinine, AST, ALT, and electrolytes (Na+, K+, Mg+) estimation. Red Cell Distribution Width/Albumin will be calculated as: ((RDW (Standard Deviation of Red Blood Cell Volume / Mean Corpuscular Volume) × 100%.) / albumin (g/L)) from admission labs. Serial: Lactate/Base Deficit at 6 hr, 12 hr, 24 hr as a monitor for proper resuscitation Calculation of Severity Scores
- R-Baux score: Age (years) + %TBSA + (17 × inhalation injury [yes=1, no=0])
- Abbreviated Burn Severity Index (ABSI): The ABSI includes five parameters: sex, age category, %TBSA, presence of full-thickness burns, and inhalation injury. Each parameter is assigned weighted points, and the total ABSI score is associated with graded survival probabilities. Both scores will be calculated on admission and compared with admission (RDW/albumin) ratio to assess relative and incremental predictive value for 30-day mortality. Supportive care:
- Early enteral nutrition, proper multimodal analgesia (paracetamol 1gm/8hr, nalbuphine 0.1mg/kg if VAS score>4), IV proton pump inhibitor to guard against curling ulcer, prophylactic anticoagulation to guard against DVT.
- Vasopressors (norepinephrine) only after adequate fluid resuscitation guided by UOP, lactate and BD if MAP below 65 mmHg. 3 - Post-Resuscitation and Definitive Management Protocol (After 72 h) Hemodynamic stabilization (post-resuscitation phase) Transition from resuscitation fluids to maintenance fluids. Avoid "fluid creep" (excess positive balance leading to pulmonary edema, abdominal compartment). → cautious use of diuretics to mobilize edema. Maintain: MAP ≥65 mmHg, urine output ≥0.5 mL/kg/h. Ongoing ventilatory support if required; lung-protective strategy for ARDS. Weaning as early as possible. Infection prevention and sepsis monitoring
- Daily wound assessment for signs of infection, weekly or targeted wound/blood cultures and antibiotics only if infection is suspected/proven (not prophylactic). Wound care and surgical management
- Regular dressing, use of negative-pressure wound therapy when indicated.
- Early excision and grafting after 72 hr. Pain and sedation control
- Multimodal analgesia, pre-procedure analgesia for dressing/grafting and long-term psychological and pain management. Rehabilitation and functional recovery • Early physiotherapy, occupational therapy for daily living skills and psychosocial support for patient and family. Criteria for transfer to ward • Hemodynamically stable, off vasopressors.
- Stable oxygenation without advanced ventilatory support.
- Tolerating enteral feeding.
- Wounds coverage completed or adequately covered with new TBSA% below 20%.
- Patients will be followed for 30 days at Ain Shams University burn unit. Measured outcomes Primary outcome: To determine the correlation between Red Cell Distribution Width/Albumin on admission and 30-day hospital mortality in burn patients. Secondary outcomes: To determine the correlation between Red Cell Distribution Width/Albumin with:
- ICU length of stay
- Hospital length of stay
- Requirements of inotropes or vasopressors
- Duration of mechanical ventilation
- To compare Red Cell Distribution Width/albumin ratio with R-Baux score as a predictor of mortality in burn patients.
- Conditions
- Burn Injuries
- Keywords
- burn, mortality, albumin, Red Cell Distribution Width
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| • Patients with burn injuries (%TBSA >20%) | each patient will be followed for 30 days for mortality prediction |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality in burn patients
To determine the correlation between Red Cell Distribution Width/Albumin on admission and 30 days hospital mortality in burn patients.
Measured: 30 days
Secondary outcomes (4)
ICU length of stay
To determine the correlation between Red Cell Distribution Width/Albumin with o ICU length of stay
Measured: 30 days
To compare RDW/albumin ratio with Revised Baux score as a predictor of mortality in burn patient.
Revised Baux score = (percent body surface burned) + (patient's age) + 17 (if inhalational injury is present) A higher Revised Baux score generally indicates a higher risk of mortality, with scores over 140 unsurvivable .
Measured: 30 days
Requirements of inotropes or vasopressors
To determine the correlation between Red Cell Distribution Width/Albumin with
- Requirements of inotropes or vasopressors
Measured: 30 days
Duration of mechanical ventilation
To determine the correlation between Red Cell Distribution Width/Albumin with
- Duration of mechanical ventilation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Aug 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuriesStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adel M Fahmy Shenouda, MD, Study chair, Department of Anesthesia, Intensive care and pain management, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761845
- Sponsor's protocol ID
- FMASU MD361/2025
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the study results will be made available upon reasonable request from qualified researchers
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Red Cell Distribution Width/Albumin Ratio as a Predictive Tool for 30-day Mortality of Patients With Burn Injuries
- ClinicalTrials.gov ID
- NCT07761845
- Acronym / sponsor ID
- FMASU MD361/2025
- Conditions
- Burn Injuries
- Keywords
- burn, mortality, albumin, Red Cell Distribution Width
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 12 Aug 2026 (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 evaluate the prognostic utility of the red cell distribution width/albumin ratio (RAR), measured within 24 hours of hospital admission, in predicting 30-day mortality among patients with burn injuries.
Detailed description
The aim of this study is to evaluate the prognostic utility of the red cell distribution width/albumin ratio (RAR), measured within 24 hours of hospital admission, in predicting 30-day mortality among patients with burn injuries.
Patients presenting with acute thermal injuries will be screened based on inclusion/exclusion criteria.
After consent, patients' characteristics (age, sex, weight), clinical parameters (total burn surface area, Abbreviated Burn Severity Index), and comorbidities will be recorded.
- Emergency Department (ED) management (Arrival and Initial Stabilization)
- Primary survey (ATLS principles): Immediate stabilization of Airway, Breathing, Circulation, Disability, Exposure (ABCDE).
- Urinary catheter insertion to monitor urine output for proper resuscitation.
- TBSA will be estimated using the Rule of Nines
- All patients will be treated during the first 24 hours after burn injury guided by the Parkland Formula.
- In-Hospital Resuscitation (0-72 h)
- Hemodynamic monitoring: ECG, pulse oximetry, respiratory rate, temperature, non-invasive blood pressure, arterial line if unstable, and central venous pressure.
- Transition to Day 2 (24-48 h post-burn): Continue Lactated Ringer's and consider colloid therapy (5% albumin or plasma) after 24 h to maintain oncotic pressure and reduce crystalloid load.
- Fluid adjustments according to urine output, mean arterial pressure with target MAP (≥65 mmHg), lactate clearance, and base deficit. Laboratory and calculation: On admission to ED, an arterial blood gas (ABG) sample will be collected to calculate base deficit (BD) and lactate level. Simultaneously, venous blood will be drawn for C-reactive protein (CRP) and serum albumin, CBC, serum urea, creatinine, AST, ALT, and electrolytes (Na+, K+, Mg+) estimation. Red Cell Distribution Width/Albumin will be calculated as: ((RDW (Standard Deviation of Red Blood Cell Volume / Mean Corpuscular Volume) × 100%.) / albumin (g/L)) from admission labs. Serial: Lactate/Base Deficit at 6 hr, 12 hr, 24 hr as a monitor for proper resuscitation Calculation of Severity Scores
- R-Baux score: Age (years) + %TBSA + (17 × inhalation injury [yes=1, no=0])
- Abbreviated Burn Severity Index (ABSI): The ABSI includes five parameters: sex, age category, %TBSA, presence of full-thickness burns, and inhalation injury. Each parameter is assigned weighted points, and the total ABSI score is associated with graded survival probabilities. Both scores will be calculated on admission and compared with admission (RDW/albumin) ratio to assess relative and incremental predictive value for 30-day mortality. Supportive care:
- Early enteral nutrition, proper multimodal analgesia (paracetamol 1gm/8hr, nalbuphine 0.1mg/kg if VAS score>4), IV proton pump inhibitor to guard against curling ulcer, prophylactic anticoagulation to guard against DVT.
- Vasopressors (norepinephrine) only after adequate fluid resuscitation guided by UOP, lactate and BD if MAP below 65 mmHg. 3 - Post-Resuscitation and Definitive Management Protocol (After 72 h) Hemodynamic stabilization (post-resuscitation phase) Transition from resuscitation fluids to maintenance fluids. Avoid "fluid creep" (excess positive balance leading to pulmonary edema, abdominal compartment). → cautious use of diuretics to mobilize edema. Maintain: MAP ≥65 mmHg, urine output ≥0.5 mL/kg/h. Ongoing ventilatory support if required; lung-protective strategy for ARDS. Weaning as early as possible. Infection prevention and sepsis monitoring
- Daily wound assessment for signs of infection, weekly or targeted wound/blood cultures and antibiotics only if infection is suspected/proven (not prophylactic). Wound care and surgical management
- Regular dressing, use of negative-pressure wound therapy when indicated.
- Early excision and grafting after 72 hr. Pain and sedation control
- Multimodal analgesia, pre-procedure analgesia for dressing/grafting and long-term psychological and pain management. Rehabilitation and functional recovery • Early physiotherapy, occupational therapy for daily living skills and psychosocial support for patient and family. Criteria for transfer to ward • Hemodynamically stable, off vasopressors.
- Stable oxygenation without advanced ventilatory support.
- Tolerating enteral feeding.
- Wounds coverage completed or adequately covered with new TBSA% below 20%.
- Patients will be followed for 30 days at Ain Shams University burn unit. Measured outcomes Primary outcome: To determine the correlation between Red Cell Distribution Width/Albumin on admission and 30-day hospital mortality in burn patients. Secondary outcomes: To determine the correlation between Red Cell Distribution Width/Albumin with:
- ICU length of stay
- Hospital length of stay
- Requirements of inotropes or vasopressors
- Duration of mechanical ventilation
- To compare Red Cell Distribution Width/albumin ratio with R-Baux score as a predictor of mortality in burn patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| • Patients with burn injuries (%TBSA >20%) | – | –each patient will be followed for 30 days for mortality prediction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with acute thermal injuries will be screened based on inclusion/exclusion criteria. After consent, Patients' characteristics (age, sex, weight), clinical parameters (Total burn surface area, Abbreviated burn severity index), and comorbidities will be recorded.
Key inclusion criteria (5 listed)
- Age > 18 years.
- Both sexes.
- Patients with burn injuries (%TBSA >20%).
- Availability of complete laboratory data (RDW, albumin) on admission.
- Admission to ICU within 24 hours of burn injury.
Key exclusion criteria (8 listed)
- Age <18 years.
- Patients with chronic hematologic disease.
- Pre-existing liver disease.
- Nephrotic syndrome.
- patients on chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality in burn patients
Time frame: 30 days
To determine the correlation between Red Cell Distribution Width/Albumin on admission and 30 days hospital mortality in burn patients.
4 secondary outcomes
ICU length of stay
Time frame: 30 days
To compare RDW/albumin ratio with Revised Baux score as a predictor of mortality in burn patient.
Time frame: 30 days
Requirements of inotropes or vasopressors
Time frame: 30 days
Duration of mechanical ventilation
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the study results will be made available upon reasonable request from qualified researchers
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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.
Ahlam M abdelnaby. study principal investigator, MBBCH, MSc . contact
Sara H Saleh, MD contact
Adel M Fahmy Shenouda, MD study chair
Department of Anesthesia, Intensive care and pain management, Faculty of Medicine, Ain Shams University
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 Burn Injuries, run by Ain Shams 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahlam M abdelnaby. study principal investigator, MBBCH, MSc . (+201120327604, g19-29502090100101@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality in burn patients (time frame: 30 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 18 Aug 2026.