- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07761845
Red Cell Distribution Width/Albumin Ratio as a Predictive Tool for Mortality of Patients With Burn Injuries
Measurement of Red Cell Distribution Width/Albumin Ratio as a Predictive Tool for 30-day Mortality of Patients With Burn Injuries
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Ahlam M abdelnaby. study principal investigator, MBBCH, MSc .
- Telefonnummer: +201120327604
- E-post: g19-29502090100101@med.asu.edu.eg
Studera Kontakt Backup
- Namn: Sara H Saleh, MD
- Telefonnummer: +201001584305
Studieorter
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypten, 11111
- Rekrytering
- Ain Shams University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
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.
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
• Patients with burn injuries (%TBSA >20%)
each patient will be followed for 30 days for mortality prediction
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
mortality in burn patients
Tidsram: 30 days
|
To determine the correlation between Red Cell Distribution Width/Albumin on admission and 30 days hospital mortality in burn patients.
|
30 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
ICU length of stay
Tidsram: 30 days
|
To determine the correlation between Red Cell Distribution Width/Albumin with o ICU length of stay
|
30 days
|
|
Requirements of inotropes or vasopressors
Tidsram: 30 days
|
To determine the correlation between Red Cell Distribution Width/Albumin with o Requirements of inotropes or vasopressors |
30 days
|
|
Duration of mechanical ventilation
Tidsram: 30 days
|
To determine the correlation between Red Cell Distribution Width/Albumin with o Duration of mechanical ventilation |
30 days
|
|
To compare RDW/albumin ratio with Revised Baux score as a predictor of mortality in burn patient.
Tidsram: 30 days
|
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 .
|
30 days
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Adel M Fahmy Shenouda, MD, Department of Anesthesia, Intensive care and pain management, Faculty of Medicine, Ain Shams University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FMASU MD361/2025
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