No registrations found.
ID
Source
Health condition
Prevalence of hypokalemia, mean potassium difference before/after bowel cleansing, age, gender, comorbidity, indication, and symptom related parameters.
Sponsors and support
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Intervention
Outcome measures
Primary outcome
Primary 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 outcome
Secondary aim: to determine risk factors for the development of hypokalemia.
Background summary
Rationale: 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.
Study objective
The use of PEG-asc could contribute a significant decrease in potassium values a potentially cause serious clinical adverse events.
Study design
Analyses will be performed after colonoscopy
Intervention
1. Clinical data registration
2. Evaluation of potassium measurements in patients before and after bowel preparation (standard health care)
Ankie Reumkens
Henri Dunantstraat 5
Heerlen 6419 PC
The Netherlands
a.reumkens@atriummc.nl
Ankie Reumkens
Henri Dunantstraat 5
Heerlen 6419 PC
The Netherlands
a.reumkens@atriummc.nl
Inclusion criteria
• All patients undergoing colonoscopy in Zuyderland Medical Center
• Age ≥18 years
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• All patients < 18 years
• Emergency colonoscopy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5416 |
| NTR-old | NTR5744 |
| Other | METC Zuyderland - Zuyd : 15-N-146 |