Organ Dysfunction ScoresGUTPHOSNCT05909722
Validation of the GIDS and Description of Phosphate Disorders
An observational study of Organ Dysfunction Scores and Hypophosphatemia, run by University of Tartu at 1 site in Estonia.
Trial summary
This study will address two specific research questions simultaneously: 1. validation of the GastroIntestinal (GI) Dysfunction score (GIDS). 2. description of epidemiology, risk factors, and management of phosphate disorders. The aim is to recruit 20 ICUs and 1500 ICU patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ Dysfunction Scores, Hypophosphatemia
- What is being tested?
- Gastrointestinal Dysfunction Score will be calculated
- How many people
- 2,681 participants
- Where
- 1 siteEstonia
- Study dates
- 8 Jan 2024to 20 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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).
Who may be able to join
- Admission to ICU during the study period
- Age ≥18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Multicentre Study to Validate the GastroIntestinal Dysfunction Score (GIDS) and Describe Prevalence, Outcomes, and Management of Phosphate Disorders in Intensive Care Patients
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.
Read the detailed description
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.
- Conditions
- Organ Dysfunction Scores, Hypophosphatemia
- Being tested
- Gastrointestinal Dysfunction Score will be calculated
- Medical subject headings
- Hypophosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastrointestinal Dysfunction Score will be calculatedDiagnostic test
Also called Phosphate levels
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 being measured
The primary outcome is the main question the study is designed to answer.
90 days mortality
Survival status at 90 days after ICU admission
Measured: 90 days
28 days mortality
Survival status at 28 days after ICU admission
Measured: 28 days
Secondary outcomes (5)
Days free of organ support
Days alive and free of organ support (including parenteral nutrition-free days) by day 28
Measured: 28 days
Prevalence of phosphate disorders at ICU admission
Prevalence of hypo- and hyperphosphatemia on ICU admission
Measured: 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
Measured: 7 days
The amount of phosphate administered
The amount of phosphate administered to patients with hypophosphatemia
Measured: 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)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start8 Jan 2024
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Organ Dysfunction ScoresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,681 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annika Reintam Blaser, University of Tartu
- Investigators
- Arthur van Zanten, PhD, Principal investigator, Gelderse Valley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909722
- Sponsor's protocol ID
- GUTPHOS study
- Acronym
- GUTPHOS
- Status last verified
- Mar 2025
- First submitted
- 29 May 2023
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34358839Melchers 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.
PubMed 39069259Kouw 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.
PubMed 39069258
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentre Study to Validate the GastroIntestinal Dysfunction Score (GIDS) and Describe Prevalence, Outcomes, and Management of Phosphate Disorders in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT05909722
- Acronym / sponsor ID
- GUTPHOS / GUTPHOS study
- Conditions
- Organ Dysfunction Scores, Hypophosphatemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,681 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (2 listed)
- Admission to ICU during the study period
- Age ≥18 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastrointestinal Dysfunction Score will be calculatedAlso: Phosphate levelsWe 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. | Diagnostic test | – |
Primary outcome
90 days mortality
Time frame: 90 days
Survival status at 90 days after ICU admission
28 days mortality
Time frame: 28 days
Survival status at 28 days after ICU admission
5 secondary outcomes
Days free of organ support
Time frame: 28 days
Prevalence of phosphate disorders at ICU admission
Time frame: Day of ICU admission (day 1)
Incidence of phosphate disorders during seven days of ICU stay
Time frame: 7 days
The amount of phosphate administered
Time frame: 7 days
Change in serum phosphate level in response to phosphate supplementation
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Background: PubMed 34358839Reintam 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.
- Derived from this study: PubMed 39069259Melchers 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.
- Derived from this study: PubMed 39069258Kouw 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur van Zanten, PhD principal investigator
Gelderse Valley Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Organ Dysfunction Scores and Hypophosphatemia, run by University of Tartu at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90 days mortality (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05909722, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.