The use of PEG-asc could contribute a significant decrease in potassium values a potentially cause serious clinical adverse events.
ID
Bron
Aandoening
Prevalence of hypokalemia, mean potassium difference before/after bowel cleansing, age, gender, comorbidity, indication, and symptom related parameters.
Ondersteuning
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
The use of PEG-asc could contribute a significant decrease in potassium values a potentially cause serious clinical adverse events.
Onderzoeksopzet
Analyses will be performed after colonoscopy
Onderzoeksproduct en/of interventie
1. Clinical data registration
2. Evaluation of potassium measurements in patients before and after bowel preparation (standard health care)
Publiek
Ankie Reumkens
Henri Dunantstraat 5
Heerlen 6419 PC
The Netherlands
a.reumkens@atriummc.nl
Wetenschappelijk
Ankie Reumkens
Henri Dunantstraat 5
Heerlen 6419 PC
The Netherlands
a.reumkens@atriummc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• All patients undergoing colonoscopy in Zuyderland Medical Center
• Age ≥18 years
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• All patients < 18 years
• Emergency colonoscopy
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL5416 |
NTR-old | NTR5744 |
Ander register | METC Zuyderland - Zuyd : 15-N-146 |