Trial reportPloS one2012
The effect of ketoconazole on post-burn inflammation, hypermetabolism and clinical outcomes.
Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Assessment of Mechanisms of Improved Wound Healing of Anabolic Agents and Diet in Severely Burned Patients
Assessment of the Treatment of the Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.
- Systematic review of clinical outcome reporting in randomised controlled trials of burn care.BMJ open · 2019Pooled it
- Pamidronate attenuates muscle loss after pediatric burn injury.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2014Trial
- Endocrine disruptions in thermal injuries: exploring immune system interactions.Physiological reviews · 2026Review
- Metabolic and Hormonal Changes in Pediatric Burn Patients: Mechanisms, Evidence, and Care Strategies.European burn journal · 2025Review
- Changes in body composition of burn patients during the phases of response to trauma.Revista brasileira de enfermagem · 2023Observational
- Burn-induced hypermetabolism and skeletal muscle dysfunction.American journal of physiology. Cell physiology · 2021Review
- A review of potential biomarkers for assessing physical and psychological trauma in paediatric burns.Burns & trauma · 2021Review
- Current problems in burn hypermetabolism.Current problems in surgery · 2020Review
- Determinants of skeletal muscle protein turnover following severe burn trauma in children.Clinical nutrition (Edinburgh, Scotland) · 2019Observational
- The P50 Research Center in Perioperative Sciences: How the investment by the National Institute of General Medical Sciences in team science has reduced postburn mortality.The journal of trauma and acute care surgery · 2017Article
- Anabolic and anticatabolic agents in critical care.Current opinion in critical care · 2016Review
- Pharmacologic blockade and genetic deletion of androgen receptor attenuates aortic aneurysm formation.Journal of vascular surgery · 2016Article
- Cardiovascular Dysfunction Following Burn Injury: What We Have Learned from Rat and Mouse Models.International journal of molecular sciences · 2016Review
- Effects of pharmacological interventions on muscle protein synthesis and breakdown in recovery from burns.Burns : journal of the International Society for Burn Injuries · 2015Review
- Curbing inflammation in burn patients.International journal of inflammation · 2013Article
- Burns: an update on current pharmacotherapy.Expert opinion on pharmacotherapy · 2012Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 4 institutions in 2 countries.
Funding
Abstract
backgroundHypercortisolemia has been suggested as a primary hormonal mediator of whole-body catabolism following severe burn injury. Ketoconazole, an anti-fungal agent, inhibits cortisol synthesis. We, therefore, studied the effect of ketoconazole on post-burn cortisol levels and the hyper-catabolic response in a prospective randomized trial (block randomization 2:1). METHODOLOGY/PRINCIPAL
findingsFifty-five severely burned pediatric patients with >30% total body surface area (TBSA) burns were enrolled in this trial. Patients were randomized to receive standard care plus either placebo (controls, n = 38) or ketoconazole (n = 23). Demographics, clinical data, serum hormone levels, serum cytokine expression profiles, organ function, hypermetabolism measures, muscle protein synthesis, incidence of wound infection sepsis, and body composition were obtained throughout the acute hospital course. Statistical analysis was performed using Fisher's exact test, Student's t-test, and parametric and non-parametric two-way repeated measures analysis of variance where applicable. Patients were similar in demographics, age, and TBSA burned. Ketoconazole effectively blocked cortisol production, as indicated by normalization of the 8-fold elevation in urine cortisol levels [F(1, 376) = 85.34, p<.001] with the initiation of treatment. However, there were no significant differences in the inflammatory response, acute-phase proteins, body composition, muscle protein breakdown or synthesis, or organ function between groups.
conclusionsBoth groups were markedly hypermetabolic and catabolic throughout the acute hospital stay. Normalization of hypercortisolemia with ketoconazole therapy had no effect on whole-body catabolism or the post-burn inflammatory or hypermetabolic response, suggesting that hypercortisolemia does not play a central role in the post-burn hypermetabolic catabolic response.
trial registrationClinicalTrials.gov NCT00675714; and NCT00673309.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.