Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202004627736636 Date of Registration: 02/04/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title LUND AND BROWDER CHART VERSUS RULE-OF-NINES IN ASSESSMENT OF ADEQUACY OF FLUID RESUSCITATION IN PATIENTS ADMITTED WITH THERMAL BURNS AT THE BURNS UNIT OF KENYATTA NATIONAL HOSPITAL
Official scientific title LUND AND BROWDER CHART VERSUS RULE-OF-NINES IN ASSESSMENT OF ADEQUACY OF FLUID RESUSCITATION IN PATIENTS ADMITTED WITH THERMAL BURNS AT THE BURNS UNIT OF KENYATTA NATIONAL HOSPITAL
Brief summary describing the background and objectives of the trial Burns are a major global health concern resulting in significant morbidity and mortality particularly in low- and middle- income countries. Adequate fluid resuscitation is one of the main cornerstones for management of severe burns. The formulae used to determine volume of fluid resuscitation are dependent on body weight in kilograms and percentage of total body surface area (% TBSA) involved. The most commonly used methods of estimation of % TBSA are Lund and Browder Chart and Wallace Rule of Nines. Fluid resuscitation is then titrated against clinical and laboratory end points of fluid resuscitation. Main Objective To compare adequacy of fluid resuscitation in patients with major thermal burns using Lund and Browder chart versus Rule-of-Nines to estimate % TBSA in patients admitted to KNH Burns Unit. Specific Objectives In patients presenting with major burns with %TBSA estimation done via Lund-Browder Chart or Wallace Rule-of-Nine: 1. Determine how fluid resuscitation influences serum lactate in the two groups of patients. 2. Ascertain how fluid resuscitation influences base deficit in the two groups of patients. 3. Establish how fluid resuscitation affects urine output in the two groups of patients 4. Correlate the urine output and the biochemical changes with morbidity and mortality. 5. Determine which of the two methods of assessing % TBSA is superior.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Burns
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/04/2017
Actual trial start date 01/06/2017
Anticipated date of last follow up 30/11/2017
Actual Last follow-up date 28/02/2018
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants) 72
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Lund and Browder Chart N/A N/A Lund and Browder Chart used to measure percentage total burn surface area 36 Historical
Experimental Group Rule of Nines N/A N/A Rule of nines method used to measure percentage total burn surface area 36
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients between 10 – 50 years old with TBSA 20% and above 2. Paediatric patients (< 10 years old) and Adult patients > 50 years old with TBSA 10% and above 3. Written informed consent or assent obtained from patient or next-of-kin 1. No written informed consent or assent obtained from patient or next of kin 2. Patients with chemical burns 3. Patients with electrical burns 4. Patients who did not meet the criteria for fluid resuscitation as per the American Burn Association guidelines 5. Patients who presented >24 hours after the burn injury 6. Patients with known comorbidities affecting kidney function such as chronic renal failure and diabetes 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Child: 6 Year-12 Year,Infant: 1 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Day(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/03/2017 Kenyatta National Hospital University of Nairobi Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
P.O Box 19676 Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Markers of fluid resuscitation - Urine Output, Serum Lactate, Base Deficit 0 hours, 8 hours, 24 hours
Primary Outcome Mortality One Week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenyatta National Hospital Hospital Road Nairobi 00202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Kenyatta National Hospital Research and Programs P.O Box 20723 Nairobi 00202 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kenyatta National Hospital P.O Box 20723 Nairobi 00202 Kenya Hospital
COLLABORATORS
Name Street address City Postal code Country
Joseph Kimani Wanjeri P.O. Box 19676 Nairobi 00202 Kenya
Ferdinand Wanjala Nangole P.O. Box 19676 Nairobi 00202 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Angela Muoki amuoki@uonbi.ac.ke +254721996133 P.O. Box 19681
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Tutorial Fellow Department of Surgery University of Nairobi
Role Name Email Phone Street address
Public Enquiries Ferdinand Nangole nangole2212@gmail.com +254714342214 P.O Box 19676
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Senior Lecturer Department of Surgery University of Nairobi
Role Name Email Phone Street address
Scientific Enquiries Joseph Wanjeri onejerry@yahoo.com +254722708051 P.O Box 19676
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Lecturer Department of Surgery University of Nairobi
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data collected from this study, including de-identified participant data, will be made available upon publication to the medical and professional communities for non-commercial purposes only, upon email request to the corresponding author. The Study Protocol, Statistical Analysis Plan and Informed Consent Form will also be made available. Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 3-6 months of publication N/A
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A Yes A total of 72 patients (36 per arm), presenting with thermal burns in the KNH Accident and Emergency Department, were recruited during the study period and allocated into the 2 groups: Group A for Lund and Browder Chart and Group B for Wallace Rule of Nines. The two groups were found to be statistically similar with regard to demographic and, injury and burn characteristics. There were no statistical differences between the two groups with regard to assessment of adequacy of fluid resuscitation: Serum lactate at 0 hours (p = .716), 8 hours (p = .876), and 24 hours (p = .164); base deficit at 0 hours (p = .314), 8 hours (p = .869), and 24 hours (p = .731); and urine output at 8 hours (p = 1.000), and at 24 hours (p = .693). The mortality rate within the first week of admission was 47.2% (34 patients). There were no statistical differences between the two groups in respect to mortality χ2 (1) = 0.223, p = .637, measures of adequacy of fluid resuscitation in the patients who died, and factors influencing mortality in burns patients (% TBSA, burn depth and presence of inhalational injury). The Lund and Browder group had a higher mean of %TBSA (52.5 ± 20.2 SD) than the Rule of Nines group (45.9 ± 20.4 SD), a not statistically significant difference of 6.6 (95% CI, -7.62 to 20.84), t (32) = 0.946, p = .351.The majority of the patients who died (44.1%) had mixed 2nd and 3rd degree burns. Of the patients who died, 88.2% had inhalational injury. In terms of the measures of adequacy of resuscitation in the patients who died, there were no significant differences between the two groups. 01/04/2020 01/04/2020
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks N/A
Changes to trial information