Trial reportThe journal of nutrition, health & aging2009
Efficacy and safety of ornithine alpha-ketoglutarate in heel pressure ulcers in elderly patients: results of a randomized controlled trial.
Trial report in The journal of nutrition, health & aging, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.
- Nutritional interventions for preventing and treating pressure ulcers.The Cochrane database of systematic reviews · 2024Pooled it
- Nutritional interventions for preventing and treating pressure ulcers.The Cochrane database of systematic reviews · 2014Pooled it
- Ornithine α-Ketoglutarate Alleviates InflammationFrontiers in nutrition · 2022Article
- Pressure Ulcer and Nutrition.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2018Review
Corrections and comments
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Authors and funding
7 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivePressure ulcers affect predominantly the elderly and nutritional status is a known risk factor. Guidelines on pressure ulcers provide recommendation on nutritional management. Ornithine alpha-ketoglutarate (OKG) is an adjuvant treatment in undernourished elderly patients or in patients with hypercatabolism states. It is a precursor of different amino-acids which play a role in the process of healing. The objective of the study is to determine the efficacy of OKG on pressure ulcer area reduction after six weeks of treatment.
designMulti-centre, international, randomized, comparative, double blind, parallel groups, placebo-controlled study.
participants160 patients (ITT population) aged over 60 years with a heel pressure ulcer at stage II or III.
interventionPatients received OKG (n=85) or placebo (n=75) once a day for 6 weeks. MEASUREMENTS: Ulcer area was measured each week, using a tracer. The primary endpoint was the percentage reduction of the surface at the final visit: [(Wound areatn - Wound areat0)/ (Wound areat0)].
resultsAt inclusion, ulcer area distribution deviated from normal distribution (median ulcer area OKG 6.6 cm(2), placebo 3.9 cm2, p=0.044, Mann-Whitney test). As healing is strongly related to baseline ulcer area, the abnormal distribution was a major bias. Therefore it was decided to perform the analysis on 2 sub-groups of patients according to the mean ulcer area, i.e. above or below 8 cm2. The mean wound area reduction for baseline area <or= 8 cm2 are -59.5 +/- 71.4% and -54.0 +/- 69.0% for the OKG group and placebo groups respectively (p=0.477, Mann-Whitney test). In the group with baseline pressure ulcer area > 8 cm2 no between group differences on either parameter was detected. When closure rate is considered, a significant difference in favor of OKG group is observed (- 0.07 cm2/day in the OKG group and - 0.04 cm2/day in the placebo groups respectively p=0.007, Mann-Whitney test). Thirty serious adverse events were reported in 28 patients (15 allocated to OKG and 13 to placebo). None of them was considered treatment related.
conclusionThis clinical trial supports a potential benefit of OKG 10g daily in the subgroup of patients with pressure ulcers <or= 8 cm2 surface area in elderly population when associated with debridement together with wound management according to pressure ulcer guidelines. However this study highlights methodological difficulties to perform clinical trials in old-old patients that may affect the robustness of the results for this type of study.
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