Intravenous Contrast Computed Tomography Versus Native Computed Tomography in Patients With Acute Abdomen and Impaired Renal Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

994 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-18

Study Completion Date

2033-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Acute Abdomen Radiocontrast Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Abdominal or body CT with intravenous contrast

Group Type EXPERIMENTAL

Abdominal or body CT with intravenous contrast

Intervention Type DIAGNOSTIC_TEST

Abdominal or body CT with intravenous contrast

Abdominal or body CT without intravenous contrast (native CT)

Group Type ACTIVE_COMPARATOR

Abdominal or body CT without intravenous contrast (native CT)

Intervention Type DIAGNOSTIC_TEST

Abdominal or body CT without intravenous contrast (native CT)

Interventions

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Abdominal or body CT with intravenous contrast

Intervention Type DIAGNOSTIC_TEST

Abdominal or body CT without intravenous contrast (native CT)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients requiring emergency abdominal or body CT with eGFR 15-45 ml/min/1.73 m2

Exclusion Criteria

* Age less than 18 years
* Pregnancy
* eGFR less than 15 or more than 45 ml/min/1.73 m2
* Renal replacement therapy within 30 days prior enrolment
* CT with IV contrast less than 72 hours prior enrolment
* Suspicion of vascular occlusion, dissection or bleeding (i.e. need for IV-contrast)
* CT needed without IV-contrast to detect or rule out ureteral stone
* IV contrast allergy
* Inability to give written consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No