Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03907631 |
| Other study ID # |
259837 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 18, 2019 |
| Est. completion date |
April 1, 2024 |
Study information
| Verified date |
April 2023 |
| Source |
Hull University Teaching Hospitals NHS Trust |
| Contact |
Sally A Myers |
| Phone |
+441482 607762 |
| Email |
sally.myers[@]hey.nhs.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Up to one third of patients with Ulcerative Colitis (UC) will require hospitalisation for
severe disease (ASUC - Acute Severe Ulcerative Colitis), often within the first 12 months of
diagnosis. 30-40% of people admitted to hospital with ASUC will require colectomy during the
emergency admission. Investigators will develop a multi-centre prospective inception cohort
of patients with ASUC with homogeneously collected detailed longitudinal clinical, endoscopic
and laboratory data.
Description:
ASUC can be a life threatening condition for which optimal management strategies within the
acute setting are required. Such strategies remain largely ill-defined with approximately 30
- 40% of ASUC inpatient admissions requiring emergency colectomy.
Intravenous corticosteroids have been the mainstay of management during the inpatient
admission but approximately 40% of this patient group will be steroid resistant. Although
mortality following emergency colectomy has indeed fallen over time, it still remains as high
as 10% at the 12 week marker. Patients with steroid refractory disease salvage therapy with
infliximab can be considered to avoid colectomy.
Currently there are no predictive indices to identify patients needing rescue therapy. Hence
health care professionals have no tools to 'personalise' care for ASUC by predicting up front
which patients fail initial medical therapy and thus predict those who may benefit from
rescue therapy or early surgery.
Traditionally the Truelove and Witts severity Index is used to define the clinical severity
of disease on admission, but this long-standing index has yet to be validated as a predictor
for the need for colectomy during the acute hospitalised phase. Similarly, endoscopic
indices, including the only validated endoscopic severity score in UC (UCEIS - Ulcerative
Colitis Endoscopic Index of Severity) have not been prospectively evaluated in the setting of
ASUC.
Approximately 30% of ASUC patients treated with rescue anti TNF will fail to respond and
require urgent colectomy. The optimal dosing regimes for rescue therapy with infliximab
remains uncertain.Recently, there have been reports of increasing use of accelerated
induction anti - TNF regimes in patients with ASUC (10mg/kg or shorter intervals) despite
lack of clear evidence to support this practice. Randomised trial evidence for selecting
patients suitable for accelerated induction regimes is not yet currently available and will
require large sample size to elucidate clearly the variables that predict the need for
individual dosing strategies.
Another consideration in the management of ASUC patients is the wide variability in practices
among institutions and clinicians; this may potentially affect quality of care and outcomes
within this cohort.
Investigators will develop a multi-centre prospective inception cohort of patients with ASUC
with homogeneously collected detailed longitudinal clinical, endoscopic, laboratory and
pharmacological data. This will facilitate development of risk prediction models in ASUC
helping early risk stratification and supporting optimized medical and surgical algorithms in
ASUC. The study will also facilitate development of a learning network in participating
centres to improve quality of care.
