Clinical trial • Not applicable • Other
IOHEXOL for Acute abdomen | Impaired renal function (eGFR 15-45 ml/min/1.73 m2)
Not applicable trial of IOHEXOL for Acute abdomen | Impaired renal function (eGFR 15-45 ml/min/1.73 m2).
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Acute abdomen | Impaired renal function (eGFR 15-45 ml/min/1.73 m2)
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 11-03-2025
- First CTIS Authorization Date
- 24-06-2025
Trial design
Randomised, open-label, two arms: (1) native (non-contrast) ct (control) and (2) intravenous contrast-enhanced ct using omnipaque 350 mg i/ml (iohexol) administered iv injection/infusion per local practice (no specific dose/schedule stated in ctis data). Not applicable trial across 9 sites in Finland, Norway.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Two arms: (1) Native (non-contrast) CT (control) and (2) Intravenous contrast-enhanced CT using Omnipaque 350 mg I/ml (iohexol) administered IV injection/infusion per local practice (no specific dose/schedule stated in CTIS data).
- Target Sample Size
- 994
- Trial Duration For Participant
- 90
Eligibility
Recruits 994 Vulnerable population selected (isVulnerablePopulationSelected=true). Informed consent is required; exclusion criterion includes "No signed written informed consent". Subject information and informed consent forms are provided (documents listed in CTIS for Finland and Norway). Participants aged <18 are excluded..
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true). Informed consent is required; exclusion criterion includes "No signed written informed consent". Subject information and informed consent forms are provided (documents listed in CTIS for Finland and Norway). Participants aged <18 are excluded.
Inclusion criteria
- {"criterion_text":"- Patients requiring emergency abdominal or body CT with eGFR 15-45 ml/min/1.73 m2. The eGFR is calculated from the last available plasma creatinine value taken maximum 24 hours before randomisation."}
Exclusion criteria
- {"criterion_text":"- Age < 18 years"}
- {"criterion_text":"- Pregnancy"}
- {"criterion_text":"- eGFR < 15 or > 45 ml/min/1.73 m2"}
- {"criterion_text":"- Renal replacement therapy within 30 days"}
- {"criterion_text":"- CT with IV contrast less than 72 hours ago"}
- {"criterion_text":"- Suspicion of vascular occlusion or dissection or bleeding (i.e. need for iv contrast)"}
- {"criterion_text":"- CT needed without iv contrast to detect or rule out ureteral stone"}
- {"criterion_text":"- IV contrast allergy"}
- {"criterion_text":"- No signed written informed consent"}
- {"criterion_text":"- Already randomised in the trial once"}
Endpoints
Primary endpoints
- {"endpoint_text":"- A composite outcome that combines all-cause mortality or renal replacement therapy within 90 days of contrast medium exposure","definition_or_measurement_approach":"Composite of all-cause mortality or initiation of renal replacement therapy occurring within 90 days after contrast medium exposure."}
Secondary endpoints
- {"endpoint_text":"- The most severe acute kidney injury (AKI) grade defined by KDIGO classification on plasma creatinine within 72 hours after CT","definition_or_measurement_approach":"Most severe AKI grade per KDIGO based on plasma creatinine measurements within 72 hours after CT."}
- {"endpoint_text":"- Any organ dysfunction defined by at least 2 mSOFA (modified Sequential Organ Failure Assessment) points excluding central nervous system 48 hours after CT","definition_or_measurement_approach":"Organ dysfunction defined as increase of ≥2 points in modified SOFA (excluding CNS) assessed 48 hours after CT."}
- {"endpoint_text":"- Alive and hospital-free days within 90 days after CT","definition_or_measurement_approach":"Number of days alive and not hospitalized during the 90 days following CT."}
- {"endpoint_text":"- Time from imaging to definitive treatment during hospital stay","definition_or_measurement_approach":"Duration (time) from imaging to definitive treatment during the index hospital admission."}
Recruitment
- Planned Sample Size
- 994
- Recruitment Window Months
- 213
- Consent Approach
- Written informed consent required from participants; exclusion includes "No signed written informed consent". Subject information and informed consent form documents are provided for Finland (Finnish) and Norway (NO) as indicated by document titles (e.g. "statement_fin", "L1_SIS adult short_NO", "L1_SIS and ICF adult_NO_V1_2"). Participants under 18 are excluded, so no assent procedures are indicated.
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 994
Finland
- Earliest CTIS Part Ii Submission Date
- 29-05-2025
- Latest Decision Or Authorization Date
- 15-08-2025
- Processing Time Days
- 78
- Number Of Sites
- 7
- Number Of Participants
- 900
Sites
- Site Name
- Etela-Pohjanmaan Sairaanhoitopiiri
- Department Name
- Surgery
- Contact Person Name
- Tarja Pinta
- Contact Person Email
- tarja.pinta@hyvaep-fi
- Site Name
- Tampere University Hospital
- Department Name
- Abdominal surgery
- Contact Person Name
- Aronen Anu
- Contact Person Email
- anu.aronen@pirha.fi
- Site Name
- Vaasa Central Hospital
- Department Name
- Abdominal surgery
- Contact Person Name
- Risto Juusela
- Contact Person Email
- risto.juusela@ovph.fi
- Site Name
- Oulu University Hospital
- Department Name
- Abdominal surgery
- Contact Person Name
- Juha Saarnio
- Contact Person Email
- juha.saarnio@oulu.fi
- Site Name
- HUS-Yhtymae
- Department Name
- Abdominal surgery
- Contact Person Name
- Panu Räty
- Contact Person Email
- panu.raty@hus.fi
- Site Name
- Central Finland Hospital District Central Finland Hospital Nova
- Department Name
- Surgery
- Contact Person Name
- Mika Ukkonen
- Contact Person Email
- mika.ukkonen@fimnet.fi
- Site Name
- Paeijaet-Haemeen hyvinvointialue
- Department Name
- surgery
- Contact Person Name
- Kapo Saukkonen
- Contact Person Email
- kapo.saukkonen@paijatha.fi
Norway
- Earliest CTIS Part Ii Submission Date
- 16-06-2025
- Latest Decision Or Authorization Date
- 22-07-2025
- Processing Time Days
- 36
- Number Of Sites
- 2
- Number Of Participants
- 94
Sites
- Site Name
- Akershus University Hospital
- Department Name
- Dpt of gastrointestinal surgery
- Contact Person Name
- Johannes Schultz
- Contact Person Email
- j.k.schultz@medisin.uio.no
- Site Name
- Oslo University Hospital HF
- Department Name
- Department Pediatric and Gastrointestinal Surgery Ullevål
- Contact Person Name
- Ole Sjo
- Contact Person Email
- olesjo@ous-hf.no
Sponsor
Primary sponsor
- Full Name
- University Of Helsinki
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- Omnipaque 350 mg I/ml Injektionslösung
- Active Substance
- IOHEXOL
- Modality
- Small molecule
- Routes Of Administration
- IV INJECTION, IV INFUSION
- Route
- IV INJECTION, IV INFUSION
- Authorisation Status
- Authorised (marketing authorisation number 0082040, authorisation country LU)
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