Validation of the GIDS and Description of Phosphate Disorders

Study Overview
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Brief Summary
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This study will address two specific research questions simultaneously: validation of the GastroIntestinal (GI) Dysfunction score (GIDS). description of epidemiology, risk factors, and management of phosphate disorders. 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.

Detailed Description
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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: Study period of a maximum of 7 days Follow-up period of a maximum of 90 days All patients will be included in the Part A of the study validating GIDS, patients from sites with routine serum phosphate measurements will be included also in the Part B of the study where additional data on serum phosphate levels and management of phosphate disorders will be collected. There will be no additional measurements due to study participation, daily routine is documented. 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.

Official Title
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Prospective, Multicentre Study to Validate the GastroIntestinal Dysfunction Score (GIDS) and Describe Prevalence, Outcomes, and Management of Phosphate Disorders in Intensive Care Patients

Conditions
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Organ Dysfunction Scores, Hypophosphatemia

Intervention / Treatment
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* Diagnostic Test: Gastrointestinal Dysfunction Score will be calculated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admission to ICU during the study period Age ≥18 years Exclusion Criteria: Age <18 years; Patients with restrictions of care such as no intubation or no renal replacement therapy on ICU admission and patients admitted for treatment as organ donors; Continuous chronic home ventilation for neuromuscular disease; Declined participation or informed consent (if the local ethics committee requests the latter for this non-interventional study); Readmission to ICU during the study period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Gastrointestinal Dysfunction Score will be calculated|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |