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This study will address two specific research questions simultaneously:
The aim is to recruit 20 ICUs and 1500 ICU patients. Sites will recruit all consecutive adult patients to a maximum of 120 patients or a maximum recruitment period of 8 weeks, whichever comes first. Daily data collection on gastrointestinal signs and symptoms as well as phosphate values and management will be collected during ICU stay for maximum of 7 days. 28 and 90 day mortality and days free of organ support will be the main outcomes. Secondary outcomes include prevalence of hypo- and hyperphosphatemia and description of their management.
Patient population All consecutive adult patients that are admitted to participating ICU during a recruitment period of maximum 8 weeks.
Duration of the study for the individual patient:
Baseline characteristics will be collected at ICU admission/study inclusion Daily data include routine data on organ dysfunctions and organ support therapies and specific data on phosphate where available.
Outcome data include 28 and 90 days mortality, and days free of organ support by day 28.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastrointestinal Dysfunction Score will be calculated | Diagnostic Test | We collect routine daily data on GI signs and symptoms and calculate the score (GIDS). We collect serum phosphate values as measured in routine practice of participating sites. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 90 days mortality | Survival status at 90 days after ICU admission | 90 days |
| 28 days mortality | Survival status at 28 days after ICU admission | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Days free of organ support | Days alive and free of organ support (including parenteral nutrition-free days) by day 28 | 28 days |
| Prevalence of phosphate disorders at ICU admission | Prevalence of hypo- and hyperphosphatemia on ICU admission |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive adult patients that are admitted to participating ICU during a recruitment period of maximum 8 weeks. In all included patients data on organ dysfunctions will be collected, in patients from sites with routine serum phosphate measurements additional data on phosphate values and management will be collected (inclusion in the Phosphate part of the study).
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| Name | Affiliation | Role |
|---|---|---|
| Arthur van Zanten, PhD | Gelderse Valley Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tartu University Hospital | Tartu | Estonia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34358839 | Background | Reintam Blaser A, Padar M, Mandul M, Elke G, Engel C, Fischer K, Giabicani M, Gold T, Hess B, Hiesmayr M, Jakob SM, Loudet CI, Meesters DM, Mongkolpun W, Paugam-Burtz C, Poeze M, Preiser JC, Renberg M, Rooijackers O, Tamme K, Wernerman J, Starkopf J. Development of the Gastrointestinal Dysfunction Score (GIDS) for critically ill patients - A prospective multicenter observational study (iSOFA study). Clin Nutr. 2021 Aug;40(8):4932-4940. doi: 10.1016/j.clnu.2021.07.015. Epub 2021 Jul 18. | |
| 39069259 |
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| ID | Term |
|---|---|
| D017674 | Hypophosphatemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Day of ICU admission (day 1) |
| Incidence of phosphate disorders during seven days of ICU stay | Incidence of hypo- and hyperphosphatemia during seven days of ICU stay | 7 days |
| The amount of phosphate administered | The amount of phosphate administered to patients with hypophosphatemia | 7 days |
| Change in serum phosphate level in response to phosphate supplementation | Chenge in serum phosphate level in response to phosphate supplementation (correction/overcorrection/no correction) | 7 days |
| Derived |
| Melchers M, Kouw IWK, Arabi YM, Casaer MP, Cotoia A, Gunst J, Malbrain MLNG, Schaller SJ, Starkopf J, Rehal MS, Blaser AR, van Zanten ARH. Prospective multicenter study to describe the prevalence, outcomes, and management of phosphate disorders in intensive care patients: Study protocol for part B of the international GUTPHOS study. Clin Nutr ESPEN. 2024 Oct;63:681-687. doi: 10.1016/j.clnesp.2024.07.024. Epub 2024 Jul 26. |
| 39069258 | Derived | Kouw IWK, Melchers M, Mandul M, Arabi YM, Casaer MP, Cotoia A, Gunst J, Malbrain MLNG, Schaller SJ, Starkopf J, Sundstrom Rehal M, Reintam Blaser A, van Zanten ARH. Prospective multicenter study to validate the gastrointestinal dysfunction score (GIDS) in intensive care patients: Study protocol for Part A of the international GUTPHOS study. Clin Nutr ESPEN. 2024 Oct;63:702-708. doi: 10.1016/j.clnesp.2024.07.023. Epub 2024 Jul 26. |