CLINICAL GUIDELINES ID TAG

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1 CLINICAL GUIDELINES ID TAG Title: Author: Speciality / Division: Directorate: Acute Colitis Protocol Dr Seamus J Murphy Gastroenterology Acute Date Uploaded: 01/06/18 Review Date June 2021 Clinical Guideline ID CG0208[1]

2 Please attach patient sticker here or record: Name:. H+C No: Hosp No: D.O.B:./ /. Male Female Acute Severe Colitis Protocol Consultant:... Ward:.. For people admitted to hospital with acute severe ulcerative colitis: ensure that a gastroenterologist and a colorectal surgeon collaborate to provide treatment and management (NICE guidance Ulcerative Colitis CG166 June 2013) Acute severe colitis is a potentially lethal condition that requires a pro-active approach with either effective medical treatment or timely colectomy Definition: Modified Truelove and Witt s Criteria for severe Ulcerative Colitis: 6 or more bloody stools per 24 hours plus any one or more of the following: Haemoglobin < 10.5; heart rate > 90; Temperature > 37.8 N.B. Rectal bleeding may not be prominent in some patients: Any patient with diarrhoea and systemic involvement should be treated per protocol Differential diagnosis: bacterial infection (C. diff, Campylobacter, etc), viral infection if immunocompromised (CMV), Crohn s colitis, ischaemia and diverticulitis. Step 1. To be completed within first hours of admission Admit patient to Medical Ward (Level 5, DHH) or Medical or Surgical Ward (CAH) Inform colorectal surgeon if patient admitted medically and vice versa. Aim of treatment: Confirm diagnosis, assess severity/extent of disease, and identify/predict complications early MEDICAL MANAGEMENT All of these interventions are equally important and require a response. DATE, INITIAL AND BLEEP NUMBER WHEN COMPLETED Clinical examination: to include PR exam Septic screen if temperature > 38ºC: blood cultures, CXR, urine dipstick, wound swabs if any Bloods: FBC, U+E, LFT, CRP, Ca, Mg, Cholesterol PRESCRIBE: 1. Enoxaparin 40mg s/c daily (20mg if egfr<30mls/min) unless patient is haemodynamically unstable from bleeding. NB: bloody diarrhoea per se is NOT a contraindication as acute colitis greatly predisposes to venous thrombosis.

3 2. I.V. hydrocortisone 100mg qid (i.e. 8am, 12MD, 4pm, 10pm) 3. Bone protection Natecal D3:1 tablet bd for as long as patient takes steroids 4. 5-ASA enemas/suppositories, (e.g. Mesalazine 1g suppository mane and Salofalk foam enema 2g nocte): these often help with urgency/incontinence symptoms 5. Oral 5-ASA at full dose e.g. Asacol MR 2.4g bd, Pentasa 2g bd. 6. Paracetamol po/iv 4 hourly PRN. Avoid NSAIDs, codeine and opiates. Abdominal XR Megacolon (>5.5cm transverse colon or >9cm caecum) Correct abnormal U+E (especially K+) and Hb if<8g/dl (see transfusion guidelines) Flexible sigmoidoscopy generally within 24 hours of admission. No bowel prep to be used. Send biopsies (2 rectal and 2 sigmoid) in 2 separate formalin pots for histology (Mark as Urgent-Acute colitis ) and 2 rectal biopsies in saline pot for CMV tissue PCR (see request form at end of protocol). If this cannot be done then a rigid sigmoidoscopy should be performed on ward (Caution: Crohn s colitis with rectal sparing will not be detected) If admitted medically: Inform colorectal surgeon of admission. If admitted surgically: Inform consultant gastroenterologist of admission NURSING MANAGEMENT DATE AND INITIAL WHEN COMPLETED 6 hourly observations as a minimum Send one stool sample for O+S and C.Difficile, use standard precautions until results back. Commence stool chart and ensure it is filled in each shift with the patient. This chart can be given to the patient to complete Weigh patient, complete Nutritional at risk score and refer to dietician Refer to IBD Nurse Mrs Ruth Hall (mobile: ) Step 2. Monitor/record DAILY Temperature and pulse 6-hourly Stool chart: Frequency, Colour / blood content Abdominal examination findings: tenderness, bowel sounds Note increasing pulse/temperature/abdominal pain or tenderness may indicate deterioration or frank perforation and requires appropriate urgent investigation and discussion with consultant. Bloods (FBC, U&E, LFT, CRP) Further AXRs if any of: fever, tachycardia, tenderness, dilatation on initial films; or if there is deterioration in the patient s condition.

4 Management Surgical liaison Any patient not settling by day 3 should be reviewed by the colorectal team. It is vital that surgeons and stoma care nurses are involved to give sufficient time for planning and also allow the patient to come to terms with possible / probable colectomy. Nutrition Malnourished patients should be considered for early calorie supplementation, either orally or naso-gastrically. Be alert to possibility of refeeding syndrome see Trust guidelines. Patients with severe disease may be nauseated and anorectic for the first day or two: they can eat normally, but may prefer a light diet or clear fluids initially. IV fluids and electrolytes Correct dehydration. Patients are highly prone to hypokalaemia due to the diarrhoea and corticosteroid therapy. Replacement doses of 60 mmol potassium per day may be required. IV antibiotics IV antibiotics ONLY in patients with toxic dilatation or if febrile with a temperature > 37.8, preferably after stool and blood cultures sent. (See SHSCT antibiotic guidelines for intra-abdominal sepsis). May be used to cover possibility of C. difficile while cultures pending: oral metronidazole should be given in this situation (400mg tid). In the absence of these features antibiotics are not routinely indicated. Day 3 assessment Day 3: If either stool frequency > 8 times per 24 hours or stool frequency > 3 times + CRP > 45, 85% likelihood of requiring colectomy if no other therapy is instigated. Note: for patients with resistant proctitis these criteria do not generally apply. Of the patients who are failing to respond, the options are iv ciclosporin, infliximab or colectomy this needs to be carefully discussed by the consultant, and discussion documented in notes. Indications for colectomy Toxic dilatation of the colon: if present on admission, hours of intensive medical therapy is warranted provided the patient is sufficiently stable. Failure to respond by 48 hours, or the development of dilatation during medical therapy mandates colectomy. Perforation Massive bleed All patients who are failing to improve on Day 3-5 should be discussed with the colorectal surgeons such that the patient is monitored closely by both medical and surgical teams and if colectomy is required this happens in a planned manner soon after day 5. Stoma Therapy will then have had a chance to review the patient, provide explanation and information. Few patients who have not made a good response to medical therapy by day 5-7 will subsequently respond, and the risks of surgery escalate with increasing delay Deterioration at any stage during admission may also necessitate urgent colectomy Laparoscopic approaches to surgery should be offered to patients where appropriate

5 Rescue therapies (IV ciclosporin and infliximab) Providing clear guidance for the choice between both these agents is impossible due to the lack of comparative trials. Infliximab may be preferred for patients with less severe colitis and in those who have already been exposed to thiopurines (azathioprine/6-mercaptopurine) since cyclosporine is particularly used as a bridge to the effect of thiopurines. One or other, but not sequential use of both rescue therapies is recommended. 1) IV Ciclosporin Provide patient with a ciclosporin patient information leaflet (e.g. C+C UK leaflet, available at: and warn of the small risk of seizures. It is contraindicated in uncontrolled hypertension, renal or liver failure, and suspected systemic infection. Pre-infusion: 1. Check Mg 2+ and cholesterol. Correct hypomagnaesaemia and low cholesterol (chol <3) (dietitician advice) if necessary. 2. Ciclosporin must be administered via a non PVC giving set as ciclosporin strips phthalate from PVC. The non PVC sets for Fresenius Kabi pumps are available from stores (Volumat Line ref VL SP90). In an emergency 4 South (under pharmacy station) or Pharmacy, CAH may have some sets. Dose: 2 mg/kg/day continuous infusion in 250mls sodium chloride 0.9% (infusion expiry 24hours). Duration: Up to 7 days. Response rate: 80% of patients with severe colitis unresponsive to iv corticosteroids will respond to iv ciclosporin. Even in relapsers the time bought can be useful to allow adjustment to the idea of colectomy and its implications. Monitoring Monitor the patient for the first 30 minutes of the first infusion since the polyethoxylated castor oil can cause anaphylactic reactions BP should be checked four times a day Ciclosporin drug levels: Check levels after 48 hours and repeat every 48 hours thereafter. 4ml blood EDTA (purple top) tube in clinical chemistry form. Blood to be taken early in morning (8am) so that it reaches Belfast by 12 midday. Phone laboratory to let them know sample being sent. Send to: Biochemistry laboratory, Kelvin Building, Grosvenor Road, RVH. Phone Renal function Ciclosporin can impair renal function in a dose related manner. If the serum creatinine rises by more than 30% from the baseline value or to >150 the dose of ciclosporin should be halved Liver function tests Ciclosporin can interfere with hepatic function in a dose related manner. If liver enzymes or bilirubin become significantly affected (twice the upper limit), reduce dose or stop therapy

6 Target range: Approximately μg/ml. N.B. Don t change infusion dose without first discussing with consultant in charge. Switching to oral ciclosporin: Stop iv ciclosporin infusion at 8pm. The next morning at 8am start oral ciclosporin as Neoral at twice the daily iv dose and give every 12 hours, at 8am and 8pm (e.g. 70 kg patient treated with 2 mg/kg/day iv ciclosporin = 140 mg daily = 140 mg bd oral ciclosporin). Discharge from Hospital: 1. Discharge home after 1-2 days of oral ciclosporin. 2. Reduce dose of oral corticosteroids by 5mg per week until stopped. 3. Prescribe PCP prophylaxis: co-trimoxazole 960mg three times a week. Half dose if nausea troublesome or in renal impairment. 4. Send TPMT levels (4ml blood EDTA (purple top) tube in clinical chemistry form) Follow-up at OP clinic: Every 1-2 weeks for 8 weeks then monthly. Check trough levels after 1 week and thereafter every 1-3 weeks. Ask patient to attend OP clinic at 9am for trough ciclosporin levels (they should NOT take their morning dose of ciclosporin until after the blood test). Start azathioprine 2.5 mg/kg/day 2 weeks after discharge when TPMT result known. Oral ciclosporin trough levels target range: Approximately μg/ml. Stop oral ciclosporin after approximately 3 months. Common interactions: Drugs which may increase ciclosporin levels: macrolides, ciprofloxacin, allopurinol, fluconazole. Drugs which may reduce ciclosporin levels: St John s Wort, rifampicin, carbamazepine. See for further information on interactions. 2) Infliximab Prior approval for use of infliximab is not required for in-patients, but it is good practice to inform them as soon as possible afterwards. Contact the cytotoxic unit in pharmacy, CAH to arrange a suitable time for the infliximab to be prepared and administered (Monday to Friday 8.30am to 4.30pm; ext 2872 or ; Brian Hamilton or Cathy Farragher). Provide patient with infliximab patient information leaflet (Available at: ). The Trust infliximab policy should be followed, and relevant forms embedded in that document completed. The patient should be counselled about the potential increased risk of: Sepsis TB reactivation (patient needs CXR in past 3 months to screen for TB) Optic atrophy / worsening MS (if patient has undiagnosed MS) Immune reactions / connective tissue disorders Cancer / lymphoma risk Follow up after discharge Patients should be reviewed two weeks after discharge in the out-patient clinic.

7 CMV colitis The clinical relevance of CMV in colitis remains uncertain but testing for CMV should be performed in all patients with acute severe colitis. Complete the CMV request form below: colonic biopsies and blood should be sent to the Regional Virus laboratory in Belfast. The Regional Virus Laboratory provides a service Monday to Friday. Specimens received before 11.30am Monday to Thursday will be reported by the next working day. Specimens received before 11.30am on a Friday will not be reported until Monday. Patients with a positive result for CMV disease (positive serology and positive colonic biopsy PCR or staining): start IV ganciclovir 5mg/kg bd (dose adjustment required in renal impairment (egfr<70) see SPC), followed with oral valganciclovir when clinically appropriate. Consult microbiology for specific advice. Ganciclovir is handled as a cytotoxic drug and is reconstituted within the cytotoxic unit in pharmacy, CAH. Contact this unit as soon as possible for ganciclovir to be prepared and administered (Monday to Friday 8.30am to 4.30pm; ext 2872 or ; Brian Hamilton or Cathy Farragher). Requests must be received before 3pm to be prepared the same day. Requests received after 3pm will be prepared the next working day. The unit will pre-prepare sufficient IV ganciclovir to commence treatment as results of specimens may not be received until after 4.30pm e.g. 6 doses will be pre-prepared on a Friday to provide sufficient doses for the weekend until the cytotoxic unit reopens. If a specimen is negative these doses will be destroyed according to the Trust s Management of Waste Policy. IV ganciclovir should only be administered by nursing staff trained to administer IV cytotoxic therapy. References: Mowat C, Cole A, Windsor A et al. Guidelines for the management of IBD in adults. Gut 2011;60(5): Van Assche G, Vermeire S, Rutgeerts P. Management of acute severe colitis. Gut 2011;60(1): Lawlor G, Moss AC. Cytomegalovirus in Inflammatory Bowel Disease: Pathogen or Innocent Bystander? Inflamm Bowel Dis 2010;16(9): NICE CG 166: Ulcerative Colitis. Management in adults, children and young people. June 2013 (Available at: This protocol was compiled by Dr Seamus J Murphy FRCP PhD, Consultant Gastroenterologist, Southern Health and Social Care Trust and is due for review in February 2016.

8 VIROLOGY REQUEST Virology for Patients with Suspected CMV Colitis AFFIX LABEL OR ENTER DETAILS LEGIBLY Send to: REGIONAL VIRUS LABORATORY, Kelvin Building, Royal Group of Hospitals Trust, Grosvenor Road, Belfast BT12 6BA. Direct Tel or RVH ext 2662 Male/Female Surname Forename D.O.B. Address Hospital No. Hospital Consultant /GP Postcode Ward / Clinic Clinical Indication Steroid Refractory Colitis in an outpatient Acute Severe colitis in a hospitalized patient Specimens Blood (NOT clotted, EDTA (Purple Top)): CMV IgG/IgM/PCR {BGCM} {BMCM} {BQCM} Colonic Biopsy (x2 in saline for virology) CMV PCR {PPVH} {PQCM} Clinical Enquiries 9-5pm OOH - RVH Switchboard Specimen type Specimen Lab use Date NB Send faeces for C Diff toxin in separate request form after CMV PCR request Signature Ensure that specimens are in a sealed plastic bag Specimen container lids should be well secured to prevent leakage in transit