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Computer tomography (CT) is the primary imaging option for acute abdominal pain in adults. Intravenous (IV) contrast media is used to improve the CT quality. In patients with impaired renal function, post-contrast acute kidney injury (PC-AKI) has remained a significant concern. Modern retrospective studies have shown no association between worsened baseline renal function and IV-contrast CT. However, no randomised controlled trial has been done to conclude this. The INCARO (INtravenous Contrast computed tomography versus native computed tomography in patients with acute Abdomen and impaired Renal functiOn) trial is a multicentre, open-label, parallel group, superiority, individually randomised controlled trial comparing IV-contrast enhanced CT to native CT in patients with impaired renal function. Patients requiring emergency abdominal or body CT with eGFR 15-45 ml/min/1.73 m2 are included in the study. The primary outcome is a composite outcome of all-cause mortality or renal replacement therapy within 90 days from CT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominal or body CT with intravenous contrast | Experimental | Abdominal or body CT with intravenous contrast |
|
| Abdominal or body CT without intravenous contrast (native CT) | Active Comparator | Abdominal or body CT without intravenous contrast (native CT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal or body CT with intravenous contrast | Diagnostic Test | Abdominal or body CT with intravenous contrast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality or renal replacement therapy | A composite outcome that combines all-cause mortality or renal replacement therapy (number of patients) | Within 90 days from CT |
| Measure | Description | Time Frame |
|---|---|---|
| Acute kidney injury (AKI) grade | The most severe acute kidney injury (AKI) grade defined by KDIGO classification on serum creatinine | Within 72 hours after CT |
| Any organ failure | Any organ failure defined by at least 2 SOFA (Sequential Organ Failure Assessment) points excluding central nervous system (number of patients) |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All-cause mortality | 6 months from CT |
| All-cause mortality | All-cause mortality | 1 year from CT |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jorvi hospital, Helsinki University Hospital | Recruiting | Espoo | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33028554 | Derived | Raty P, Mentula P, Lampela H, Nykanen T, Helantera I, Haapio M, Lehtimaki T, Skrifvars MB, Vaara ST, Leppaniemi A, Sallinen V. INtravenous Contrast computed tomography versus native computed tomography in patients with acute Abdomen and impaired Renal functiOn (INCARO): a multicentre, open-label, randomised controlled trial - study protocol. BMJ Open. 2020 Oct 6;10(10):e037928. doi: 10.1136/bmjopen-2020-037928. |
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| Abdominal or body CT without intravenous contrast (native CT) | Diagnostic Test | Abdominal or body CT without intravenous contrast (native CT) |
|
| 48 hours after CT |
| Alive and hospital-free | Alive and hospital-free (days) | Within 90 days after CT |
| Time from CT to definitive treatment | Time from CT to definitive treatment (i.e. surgery, radiological intervention, endoscopy, medication) | During hospital stay estimated on average 7 days |
| All-cause mortality | All-cause mortality | 5 years from CT |
| All-cause mortality | All-cause mortality | 10 years from CT |
| Renal replacement therapy | Number of patients requiring renal replacement therapy | 6 months from CT |
| Renal replacement therapy | Number of patients requiring renal replacement therapy | 1 year from CT |
| Renal replacement therapy | Number of patients requiring renal replacement therapy | 5 years from CT |
| Renal replacement therapy | Number of patients requiring renal replacement therapy | 10 years from CT |
| Renal transplant | Number of patients undegoing renal transplant | 6 months from CT |
| Renal transplant | Number of patients undegoing renal transplant | 1 year from CT |
| Renal transplant | Number of patients undegoing renal transplant | 5 years from CT |
| Renal transplant | Number of patients undegoing renal transplant | 10 years from CT |
| Meilahti hospital, Helsinki University Hospital | Recruiting | Helsinki | 00029 | Finland |
|
| Hyvinkää hospital | Recruiting | Hyvinkää | 00029 | Finland |
|
| ID | Term |
|---|---|
| D000006 | Abdomen, Acute |
| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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