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Active, Not Recruiting

NCT Number: NCT03907631

Multi-centre Acute Severe Ulcerative Colitis Prospective Cohort Study (Elevate ASUC)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastroenterology, Hull Royal Infirmary, Hull University Teaaching Hospitals NHS Trust

Hull, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18 - 80 years.
  • Confirmed acute severe ulcerative colitis based on modified Truelove and Witts criteria requiring hospital admission.
  • Need for at least 2 days of intravenous steroids
  • Able to sign consent

Exclusion criteria

  • Crohn's disease
  • Admission for elective colectomy
  • Infective colitis confirmed on stool culture, assays for C. difficile or cytomegalovirus
  • Pregnancy
  • Inability to sign consent
  • Prior colitis related surgery - pouch, stoma

Treatment and study plan

Standard of care

Other

care decisions driven by local physicians; this is an observational cohort

Primary outcomes

  1. In Hospital Outcomes

    Time frame: 30 days

    Response assessed by the following clinical care decisions based on binary outcomes: need for rescue therapy (yes = 1 or no =), need for accelerated induction (yes = 1 or no = 0), need for surgery during index admission (yes = 1 or no = 0)

  2. Colectomy rates

    Time frame: 30 days

    Proportion of patients needing colectomy

Secondary outcomes

  1. Long-term response to medical management

    Time frame: day 90 and 12 month time points

    Response assessed by the following clinical care decisions based on binary outcomes: Colectomy free survival at strategic time points (yes = 1 or no = 0)

  2. Risk factors for need for rescue

    Time frame: 30

    Analysis of risk factors predicting need for rescue

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Registry information

Official study title

Elevate ASUC - Evaluating Clinical and Endoscopic Variables in Assessment, Treatment and Outcome Endpoints in Acute Severe Ulcerative Colitis

Acronym: ELEVATE-ASUC

Important dates

Study start
2019
Primary completion
2024
Study completion
2026
First posted
Apr 9, 2019
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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