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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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

+201120327604

g19-29502090100101@med.asu.edu.eg

Sara H Saleh, MD contact

+201001584305

Egypt1 site, 1 recruiting
  • Ain shams university

    Cairo, Cairo Governorate, 11111

    Recruiting

Other trials in Egypt

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.

  1. 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.
  1. 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 groups in NCT07761845
Study groupRoleWhat 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.

  1. 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)
  1. ICU length of stay

    To determine the correlation between Red Cell Distribution Width/Albumin with o ICU length of stay

    Measured: 30 days

  2. 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

  3. Requirements of inotropes or vasopressors

    To determine the correlation between Red Cell Distribution Width/Albumin with

    • Requirements of inotropes or vasopressors

    Measured: 30 days

  4. 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.

  1. First posted12 Aug 2026
  2. Study start1 Aug 2026
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

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
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

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.

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