- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Ahlam M abdelnaby. study principal investigator, MBBCH, MSc .
- Numer telefonu: +201120327604
- E-mail: g19-29502090100101@med.asu.edu.eg
Kopia zapasowa kontaktu do badania
- Nazwa: Sara H Saleh, MD
- Numer telefonu: +201001584305
Lokalizacje studiów
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egipt, 11111
- Rekrutacyjny
- Ain Shams University
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
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.
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
• Patients with burn injuries (%TBSA >20%)
each patient will be followed for 30 days for mortality prediction
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
mortality in burn patients
Ramy czasowe: 30 days
|
To determine the correlation between Red Cell Distribution Width/Albumin on admission and 30 days hospital mortality in burn patients.
|
30 days
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
ICU length of stay
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Adel M Fahmy Shenouda, MD, Department of Anesthesia, Intensive care and pain management, Faculty of Medicine, Ain Shams University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- FMASU MD361/2025
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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