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CompletedNCT05909722GUTPHOSUpdated Mar 25, 2025

Validation of the GIDS and Description of Phosphate Disorders

An observational study in Organ Dysfunction Scores and Hypophosphatemia, sponsored by University of Tartu. Completed at 1 site in Estonia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-25.

Sponsored by University of Tartu · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,681
Ages
18 Years and older
Sex
All
01

Study 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. 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:

  1. Study period of a maximum of 7 days
  2. 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.

02

Conditions studied

  • Organ Dysfunction Scores
  • Hypophosphatemia

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03

In context

Hypophosphatemia

53 studies on the registry are indexed under Hypophosphatemia; 16 are open to participants now.

This study's enrollment of 2,681 is above the median of 105 across 26 observational studies indexed under Hypophosphatemia.

Browse Hypophosphatemia studies →

Lead sponsor

University of Tartu is the lead sponsor of 46 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Admission to ICU during the study period
  • Age ≥18 years

Exclusion criteria

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 (if the local ethics committee requests the latter for this non-interventional study);
  • Readmission to ICU during the study period
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,681 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testGastrointestinal 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.

    Also known as: Phosphate levels

06

What researchers measure

Primary outcomes

  1. 90 days mortality

    Survival status at 90 days after ICU admission

    Time frame: 90 days

  2. 28 days mortality

    Survival status at 28 days after ICU admission

    Time frame: 28 days

Secondary outcomes

  1. Days free of organ support

    Days alive and free of organ support (including parenteral nutrition-free days) by day 28

    Time frame: 28 days

  2. Prevalence of phosphate disorders at ICU admission

    Prevalence of hypo- and hyperphosphatemia on ICU admission

    Time frame: Day of ICU admission (day 1)

  3. Incidence of phosphate disorders during seven days of ICU stay

    Incidence of hypo- and hyperphosphatemia during seven days of ICU stay

    Time frame: 7 days

  4. The amount of phosphate administered

    The amount of phosphate administered to patients with hypophosphatemia

    Time frame: 7 days

  5. Change in serum phosphate level in response to phosphate supplementation

    Chenge in serum phosphate level in response to phosphate supplementation (correction/overcorrection/no correction)

    Time frame: 7 days

07

Study locations

1 site
  • Tartu University Hospital
    Tartu, Estonia
08

References and documents

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 34358839 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2024 to primary completion in Dec 2024, 11 months.

Of 14 observational studies under Hypophosphatemia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 29, 2023
First posted
Jun 18, 2023
StartActual
Jan 8, 2024
Primary completionActual
Dec 20, 2024
CompletionActual
Dec 20, 2024
Last update
Mar 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05909722
Lead sponsor
University of Tartu
Responsible party
Annika Reintam Blaser (Associate Professor, University of Tartu) — Principal investigator
First posted
Jun 18, 2023
Start date
Jan 8, 2024
Primary completion
Dec 20, 2024
Completion
Dec 20, 2024
Last update
Mar 25, 2025

Study contacts

Arthur van Zanten, PhD
principal investigator · Gelderse Valley Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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