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van CCT (UK)

van CCT (UK)

Potassium values before and after PEG-asc for colonoscopy

- candidate number24208
- NTR NumberNTR5744
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-apr-2016
- Secondary IDs15-N-146 METC Zuyderland - Zuyd
- Public TitlePotassium values before and after PEG-asc for colonoscopy
- Scientific TitlePotassium values before and after PEG-asc for colonoscopy; prevalences, mean differences and potential risk factors
- hypothesisThe use of PEG-asc could contribute a significant decrease in potassium values a potentially cause serious clinical adverse events.
- Healt Condition(s) or Problem(s) studiedHypokalemia, Colonoscopy
- Inclusion criteria All patients undergoing colonoscopy in Zuyderland Medical Center
Age ≥18 years
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
All patients < 18 years
Emergency colonoscopy
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 4-jan-2016
- planned closingdate4-jul-2016
- Target number of participants2000
- Interventions1. Clinical data registration
2. Evaluation of potassium measurements in patients before and after bowel preparation (standard health care)
- Primary outcomePrimary aim. The primary study endpoint will be the detection of hypokalaemia, which is defined as a potassium value < 3.5 mmol/L at t0 and t1.
- Secondary outcomeSecondary aim: to determine risk factors for the development of hypokalemia.
- TimepointsAnalyses will be performed after colonoscopy
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD candidate Ankie Reumkens
- CONTACT for SCIENTIFIC QUERIESMD, PhD candidate Ankie Reumkens
- Sponsor/Initiator Zuyderland Medical Center, Heerlen
- Funding
(Source(s) of Monetary or Material Support)
Zuyderland Medical Center, Heerlen
- Publicationsin progress
- Brief summaryRationale: Patients undergoing colonoscopy could have an (unknown) risk of hypokalaemia due to bowel cleansing and other risk factors, such as comorbidity and age. Patients with pre-existing hypokalaemia are at risk for severe hypokalaemia. By performing this study, we want to define risk factors and provide a new protocol for bowel cleansing in our hospital.

Objective: All patients undergoing colonoscopy.

Study design: Population-based, observational study

Study population: All patients undergoing colonoscopy ≥ 18 years old.

Main study parameters/endpoints: Prevalence of hypokalaemia, mean potassium difference before/after bowel cleansing, age, gender, comorbidity, indication, and symptom related parameters.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: To minimize the risks for patients undergoing colonoscopy we will check potassium values as standard care. The existing protocol will be expanded for all patients. Every ambulatory patient visits the screening nurse for information and risk stratification. One blood sample is obtained approximately 1 week before start of bowel cleansing and one blood sample via intravenous needle (already needed for infusion of analgesics and sedation) on the day of colonoscopy.
- Main changes (audit trail)
- RECORD8-apr-2016 - 22-mei-2016

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