Metabolic Rate in Burns

NCT03024931 | Unknown

• 1 other identifier: qw
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Severe burn patients are some of the most challenging critically ill patients with an extreme and continuous state of physiological stress. Patients tends to stay for a long period of time in intensive care unit to treat burns as well as dealing with complications that arises from the initial burns injury. Severe burns patients are notoriously known to loose weight. The word 'catabolism' is used medically. This theory of catabolism after a trauma was hypothesised in 1942 by Professor Curthberston and based on animal models. Since this date, despite medical technological advancement, there has been no research that confirms Professor Curthberston's theory. Investigators still do not know the exact mechanism by which the body changes from conserving energy to becoming catabolic. Furthermore, it remains unclear whether this change in catabolism is necessary to heal from burns injury. This theoretical catabolism in burns patients is currently treated with nutritional supplement, use of medications including beta-blockers (suppresses heart rate and decreases blood pressure) and oxandrolone (formula which is similar to testosterone to build up muscles). There are evidences to suggest that increase in weight loss worsens the outcome in burns injury. Both overfeeding or underfeeding patients can be detrimental. In this research, the exact changes in metabolic rate will be measured in the first 72 hours of the study using a calorimetry machine. In addition to the metabolic rate, the response to the heart, liver, kidneys and hormonal levels will be measured. By looking into these dynamic changes the investigator will be able to elucidate whether there is a real increase in metabolic rate. If there is, the investigator would also be able to tell the response of different organs and whether there are any hormones that could be responsible to inflicting the metabolic changes.

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• Monitor the change in resting metabolic rate over period of time after severe burns injury.

  The resting metabolic rate will be measured using Quark Indirect Calorimetry Machine from Cosmed, Italy. The rested metabolic rate will be measured in kilo calories.

  Continuous monitoring over 72 hours

Secondary Outcomes (2)

• Monitor the cardiac output using Fick principle in severe burns

  The cardiac output will be measured using the fick principle.The cardiac output will be measured at 12th, 24th, 36th, 48th, 60th 72nd hour from the point of the injury. 10 patients will be recruited over a year.

• Monitor the splanchnic circulation by measuring the indocyanine green clearance rate.

  The splanchnic circulation will be measured at 12th, 24th, 36th, 48th, 60th 72nd hour from the point of the injury. 10 patients will be recruited over a year.

Interventions

observational study OTHER

No intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators plan to study 10 adult patients with severe burns participants within the first 72 hours of admission to the BICU. Participants will be recruited from the burns intensive care adult unit (BICU), CWFT, London, UK. Inclusion and exclusion criteria are below.

You may qualify if:

• Male or female, aged 16 years or over
• Informed, written consent from patient. If the participant is unable to give consent then assent will be considered.
• Burns more than 15%
• Acute presentation

You may not qualify if:

• Any concern from the clinical team that the application or ongoing presence of the monitoring device would interfere with optimal patient management.
• Allergy to adhesives used for monitor leads and belts.
• Participants below 16 years old
• Burns less than 5%
• Conditions that gives an inaccurate calorimetry results
• Participants needing oxygen concentration more than 60%
• Participants who have broncho-alveolar fistula
• Participants with chest drains
• Airway leak within the ventilated systems

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead

Study Sites (1)

The Burn Intensive Care Unit (BICU), Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

RECRUITING

Related Publications (9)

• Herndon DN, Hart DW, Wolf SE, Chinkes DL, Wolfe RR. Reversal of catabolism by beta-blockade after severe burns. N Engl J Med. 2001 Oct 25;345(17):1223-9. doi: 10.1056/NEJMoa010342.

  PMID: 11680441 RESULT

• Huang YS, Yang ZC, Liu XS, Chen FM, He BB, Li A, Crowther RS. Serial experimental and clinical studies on the pathogenesis of multiple organ dysfunction syndrome (MODS) in severe burns. Burns. 1998 Dec;24(8):706-16. doi: 10.1016/s0305-4179(98)00123-5.

  PMID: 9915670 RESULT

• Jeschke MG, Gauglitz GG, Kulp GA, Finnerty CC, Williams FN, Kraft R, Suman OE, Mlcak RP, Herndon DN. Long-term persistance of the pathophysiologic response to severe burn injury. PLoS One. 2011;6(7):e21245. doi: 10.1371/journal.pone.0021245. Epub 2011 Jul 18.

  PMID: 21789167 RESULT

• Jeschke MG, Herndon DN, Wolf SE, DebRoy MA, Rai J, Lichtenbelt BJ, Barrow RE. Recombinant human growth hormone alters acute phase reactant proteins, cytokine expression, and liver morphology in burned rats. J Surg Res. 1999 May 15;83(2):122-9. doi: 10.1006/jsre.1999.5577.

  PMID: 10329105 RESULT

• Kasten KR, Makley AT, Kagan RJ. Update on the critical care management of severe burns. J Intensive Care Med. 2011 Jul-Aug;26(4):223-36. doi: 10.1177/0885066610390869.

  PMID: 21764766 RESULT

• CUTHBERTSON DP. Interrelationship of metabolic changes consequent to injury. Br Med Bull. 1954;10(1):33-7. doi: 10.1093/oxfordjournals.bmb.a069369. No abstract available.

  PMID: 13126521 RESULT

• CUTHBERTSON DP. Nutrition. Annu Rev Med. 1953;4:135-62. doi: 10.1146/annurev.me.04.020153.001031. No abstract available.

  PMID: 13105270 RESULT

• Bell JR, Clark AM, Cuthbertson DP. Experimental traumatic shock. J Physiol. 1938 May 14;92(4):361-70. doi: 10.1113/jphysiol.1938.sp003608. No abstract available.

  PMID: 16994980 RESULT

• Cathcart EP, Cuthbertson DP. The composition and distribution of the fatty substances of the human subject. J Physiol. 1931 Jul 6;72(3):349-60. doi: 10.1113/jphysiol.1931.sp002779. No abstract available.

  PMID: 16994214 RESULT

MeSH Terms

Conditions

Burns

Interventions

Observation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Marcela Vizcaychipi

  Chelsea and Westminster NHS trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asako Shida

CONTACT

07957497542; ashida@imperial.ac.uk

Marcela Vizcaychipi

CONTACT

02087468903; m.vizcaychipi@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Anaesthesia and Intensive Care Medicine Honorary Senior Clinical Lecturer Divisional Research Lead for Planned Care Surgery and Clinical Support

Study Record Dates

• First Submitted: December 3, 2016
• First Posted: January 19, 2017
• Study Start: January 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)