Renal ImpairmentBC-RIMPNCT05349851
Bowel Cleansing With Renal Impairment
An observational study of Renal Impairment and Adverse Effects of Medical Drugs, run by Marco Antonio Alvarez Gonzalez at 2 sites in Spain.
Trial summary
Bowel preparation for colonoscopy requires the administration of large amounts of fluids that can cause fluid and electrolyte disturbances and volume overload, especially in patients with advanced renal failure. Polyethylene glycol-based regimens are considered safe, even in patients with advanced renal failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Impairment, Adverse Effects of Medical Drugs
- What is being tested?
- Follow-up with blood and urine analysis
- How many people
- 237 participants
- Where
- 2 sitesSpain
- Study dates
- 5 Oct 2021to 31 Mar 2024
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients with a scheduled colonoscopy for any indication and with moderate or severe renal impairment
Who may be able to join
- Outpatients or hospitalized patients with previously scheduled colonoscopy with any indication: screening, follow-up or symptoms.
- Diagnosis of stage 3B-5D chronic renal failure (creatinine clearance less than 45 ml / min / 1.73 m2).
Who cannot join
- Age less than 18 years or greater than 80 years
- Partial or total colectomy
- Severe constipation
- Active inflammatory bowel disease
- Severe hepatic impairment (Child Pugh Classification C)
- Pregnancy or breastfeeding
- Refusal to authorize the clinical registration of the information
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Althaia Xarxa Assistencial Universitària de Manresa
Manresa, Catalonia, 08243
Raúl Velamazán, MD, PhD
- Recruiting
Hospital Reina Sofía
Tudela, Navarre
Diego Martínez, MD
About this study
Official title: Clinical Registry of Adverse Effects in the Preparation for Colonoscopy in Patients With Advanced Renal Failure
Bowel preparation for colonoscopy requires the administration of large amounts of fluids that can cause fluid and electrolyte disturbances and volume overload, especially in patients with advanced renal failure. Polyethylene glycol-based regimens are considered safe, even in patients with advanced renal failure. However, the incidence of adverse effects (AEs) in routine clinical practice is unknown. The main objective of this study is to carry out a prospective, observational, multicenter clinical registry of renal AE of the preparation for colonoscopy, in patients with advanced renal failure, within the usual clinical practice of the preparation. Variables related to kidney function, bowel-cleansing efficacy, and tolerance will also be recorded. A segmented analysis will be performed in patients with substitutive renal therapy (hemodialysis or peritoneal dialysis).
Read the detailed description
Introduction: Bowel preparation for colonoscopy requires the administration of large amounts of fluids that can cause fluid and electrolyte alterations and volume overload, especially in patients with advanced renal failure. Routine clinical practice of bowel preparation with polyethylene glycol-based regimens, including in patients with advanced renal failure, is considered safe. The hydroelectrolytic AEs and worsening of renal failure are generally mild and transient. However, the incidence of AEs in routine clinical practice is unknown, because there is no prospective record of the incidence of renal AEs in these patients.
Objectives:
- Principal. To carry out a clinical registry of the renal AEs of the preparation for colonoscopy, in patients with advanced renal failure, within the usual clinical practice of the preparation.
- Secondary:
- Study the efficacy of intestinal cleansing using the Boston bowel preparation scale.
- Study the patient-reported experience measures (PREMs) in terms of tolerability and acceptance of bowel preparation.
Study of the population and sample size: Outpatients with a scheduled colonoscopy for any indication and with moderate or severe renal impairment. Ages: 18-80, excluding partial colectomy, severe constipation, active intestinal disease, severe heart or liver failure, pregnancy or lactation, and refusal to authorize the clinical record of information. We calculated a sample size of 237 subjects to show an incidence of renal AD of 10%, with a precision of 4%.
Methods: Identify patients with a scheduled colonoscopy who present advanced renal failure, in the 60 days prior to the colonoscopy. Carry out a prospective, observational, multicenter clinical registry of the routine clinical practice of preparation for colonoscopy. Variables related to renal function, the efficacy of intestinal cleansing, and tolerance will be recorded. A segmented analysis will be performed in patients with substitutive renal therapy (hemodialysis or peritoneal dialysis). The data will be collected on the REDCap-AEG online platform, which can be accessed by researchers from each center through an identification code, respecting the current Organic Law on Data Protection.
- Conditions
- Renal Impairment, Adverse Effects of Medical Drugs
- Being tested
- Follow-up with blood and urine analysis
- Keywords
- Colonoscopy, Bowel cleansing, Renal impairment, Hydroelectrolytic adverse effects
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up with blood and urine analysisOther
The patients will receive the preparation standards according to the usual clinical practice of each center. On the day of the colonoscopy, patient will be informed about this study and the informed consent will be requested to record the study information. Then, an analysis will be carried out. A second visit will be carried out, follow-up at 3-7 days, which will include a clinical interview and an analysis, being the unique intervention that patients receive.
| Study group | Role | What they receive |
|---|---|---|
| Renal failure patiens | Patients with advanced renal failure Receives: Other: Follow-up with blood and urine analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global incidence of renal adverse effects (AEs)
Global incidence of renal adverse effects (AEs) (yes/no) if any of the following variables have an abnormal value in serum: sodium, potassium, calcium, chloride, bicarbonate, creatinine, or the glomerular filtrate rate calculated with the MDRD formula and the CKD-EPI formula.
Measured: 3 hours to 7 days after laxative intake
Secondary outcomes (21)
Serum sodium concentration
Any abnormal value in serum sodium concentration.
Measured: 3 hours to 7 days after laxative intake
Serum potasium concentration
Any abnormal value in serum potasium concentration.
Measured: 3 hours to 7 days after laxative intake
Serum ionized calcium concentration
Any abnormal value in serum ionized calcium concentration.
Measured: 3 hours to 7 days after laxative intake
Serum chloride concentration
Any abnormal value in serum chloride concentration.
Measured: 3 hours to 7 days after laxative intake
Serum bicarbonate concentration
Any abnormal value in serum bicarbonate concentration.
Measured: 3 hours to 7 days after laxative intake
Serum creatinine concentration
Any abnormal value in serum creatinine concentration.
Measured: 3 hours to 7 days after laxative intake
Glomerular filtration rate
Glomerular filtration rate calculated with the MDRD formula and the CKD-EPI formula.
Measured: 3 hours to 7 days after laxative intake
Serum phosphorus concentration
Any abnormal value in serum phosphorus concentration.
Measured: 3 hours to 7 days after laxative intake
Serum magnesium concentration
Any abnormal value in serum magnesium concentration.
Measured: 3 hours to 7 days after laxative intake
Blood pH
Blood pH measurement
Measured: 3 hours to 7 days after laxative intake
Hemoglobin concentration
Mean corpuscular hemoglobin
Measured: 3 hours to 7 days after laxative intake
Blood platelets
Number of blood platelets
Measured: 3 hours to 7 days after laxative intake
Adequate bowel cleansing for colonoscopy
Application of the Boston Bowel Preparation Scale to evaluate colonoscopy bowel cleansing. The efficacy of bowel preparation will be rated by blinded endoscopists using the Boston Bowel Preparation Scale (BBPS). Adequate bowel cleansing will be defined as a BBPS of 2 or more points in every segment of the colon and inadequate bowel cleansing will be defined by at least one of the colon segments with less than 2 points.
Measured: At the moment of colonoscopy
Adhrence to laxative intake
Adhrence to laxative intake recorded as >75% of the quantity of laxative intake reported in a questionarie administered with the help of an investigator.
Measured: 3-5 hours after laxative intake (at the colonoscopy appointment)
Time from last intake of laxative to the colonoscopy
Interval in hours between last intake of laxative and the colonoscopy.
Measured: 3-5 hours after laxative intake (at the colonoscopy appointment)
Patient-reported experience measures (PREMs) questionnaire of laxative intake
Patient-reported experience measures (PREMs) questionnaire of laxative intake, administered with the help of an investigator. Descriptive subjective scale: Very bad, bad, average, good, very Good.
Measured: 3-5 hours after laxative intake (at the colonoscopy appointment)
Early side effects of laxative intake
Early side effects of laxative intake. Structured questionnaire nausea, vomiting, dizziness, thirst, headache, abdominal bloating. Non structured for other side effects.
Measured: 3-5 hours after laxative intake (at the colonoscopy appointment)
Late side effects of laxative intake
Structured questionnaire nausea, vomiting, dizziness, thirst, headache, abdominal bloating, abdominal pain, mental confusion, asthenia, dyspnea, peripheral edema. Non structured for other side effects.
Measured: 3-7 days after laxative intake
Need of urgent consultation
Number of participants requiring medical consultation for kidney related problems, including emergency room or nephrologist consultation.
Measured: 3 hours to 7 days after laxative intake
Need for hospital admission
Number of participants requiring hospital admission for any kidney related causes.
Measured: 3 hours to 7 days after laxative intake
Need of any drug treatment, new treatment or modification, that may affect kidney function or serum electrolytes
Number of participants that require outpatient medication change after the intervention.
Measured: 3 hours to 7 days after laxative intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start5 Oct 2021
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 237 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Marco Antonio Alvarez Gonzalez
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario de Navarra, Althaia Xarxa Assistencial Universitària de Manresa
- Responsible party
- Sponsor-investigator, Marco Antonio Alvarez Gonzalez, Parc de Salut Mar
- Investigators
- Marco A Álvarez, MD, PhD, Principal investigator, Althaia Xarxa Assistencial Universitària de Manresa; Institut Hospital del Mar d'investigacions mèdiques, Barcelona.Eduardo Albéniz, MD, PhD, Principal investigator, Hospital Universitario de Navarra; Navarrabiomed; UPNA; IdiSNA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349851
- Sponsor's protocol ID
- 2020/9515
- Acronym
- BC-RIMP
- Status last verified
- Nov 2023
- First submitted
- 31 Mar 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Registry of Adverse Effects in the Preparation for Colonoscopy in Patients With Advanced Renal Failure
- ClinicalTrials.gov ID
- NCT05349851
- Acronym / sponsor ID
- BC-RIMP / 2020/9515
- Conditions
- Renal Impairment, Adverse Effects of Medical Drugs
- Keywords
- Colonoscopy, Bowel cleansing, Renal impairment, Hydroelectrolytic adverse effects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 237 participants (estimated)
- Lead sponsor
- Marco Antonio Alvarez GonzalezUniversity, hospital or other
- Collaborators
- Complejo Hospitalario de Navarra, Althaia Xarxa Assistencial Universitària de Manresa
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bowel preparation for colonoscopy requires the administration of large amounts of fluids that can cause fluid and electrolyte disturbances and volume overload, especially in patients with advanced renal failure. Polyethylene glycol-based regimens are considered safe, even in patients with advanced renal failure. However, the incidence of adverse effects (AEs) in routine clinical practice is unknown. The main objective of this study is to carry out a prospective, observational, multicenter clinical registry of renal AE of the preparation for colonoscopy, in patients with advanced renal failure, within the usual clinical practice of the preparation. Variables related to kidney function, bowel-cleansing efficacy, and tolerance will also be recorded. A segmented analysis will be performed in patients with substitutive renal therapy (hemodialysis or peritoneal dialysis).
Detailed description
Introduction: Bowel preparation for colonoscopy requires the administration of large amounts of fluids that can cause fluid and electrolyte alterations and volume overload, especially in patients with advanced renal failure. Routine clinical practice of bowel preparation with polyethylene glycol-based regimens, including in patients with advanced renal failure, is considered safe. The hydroelectrolytic AEs and worsening of renal failure are generally mild and transient. However, the incidence of AEs in routine clinical practice is unknown, because there is no prospective record of the incidence of renal AEs in these patients.
Objectives:
- Principal. To carry out a clinical registry of the renal AEs of the preparation for colonoscopy, in patients with advanced renal failure, within the usual clinical practice of the preparation.
- Secondary:
- Study the efficacy of intestinal cleansing using the Boston bowel preparation scale.
- Study the patient-reported experience measures (PREMs) in terms of tolerability and acceptance of bowel preparation.
Study of the population and sample size: Outpatients with a scheduled colonoscopy for any indication and with moderate or severe renal impairment. Ages: 18-80, excluding partial colectomy, severe constipation, active intestinal disease, severe heart or liver failure, pregnancy or lactation, and refusal to authorize the clinical record of information. We calculated a sample size of 237 subjects to show an incidence of renal AD of 10%, with a precision of 4%.
Methods: Identify patients with a scheduled colonoscopy who present advanced renal failure, in the 60 days prior to the colonoscopy. Carry out a prospective, observational, multicenter clinical registry of the routine clinical practice of preparation for colonoscopy. Variables related to renal function, the efficacy of intestinal cleansing, and tolerance will be recorded. A segmented analysis will be performed in patients with substitutive renal therapy (hemodialysis or peritoneal dialysis). The data will be collected on the REDCap-AEG online platform, which can be accessed by researchers from each center through an identification code, respecting the current Organic Law on Data Protection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal failure patiens | – | Other: Follow-up with blood and urine analysisPatients with advanced renal failure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients with a scheduled colonoscopy for any indication and with moderate or severe renal impairment
Key inclusion criteria (2 listed)
- Outpatients or hospitalized patients with previously scheduled colonoscopy with any indication: screening, follow-up or symptoms.
- Diagnosis of stage 3B-5D chronic renal failure (creatinine clearance less than 45 ml / min / 1.73 m2).
Key exclusion criteria (7 listed)
- Age less than 18 years or greater than 80 years
- Partial or total colectomy
- Severe constipation
- Active inflammatory bowel disease
- Severe hepatic impairment (Child Pugh Classification C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-up with blood and urine analysisThe patients will receive the preparation standards according to the usual clinical practice of each center. On the day of the colonoscopy, patient will be informed about this study and the informed consent will be requested to record the study information. Then, an analysis will be carried out. A second visit will be carried out, follow-up at 3-7 days, which will include a clinical interview and an analysis, being the unique intervention that patients receive. | Other | Renal failure patiens |
Primary outcome
Global incidence of renal adverse effects (AEs)
Time frame: 3 hours to 7 days after laxative intake
Global incidence of renal adverse effects (AEs) (yes/no) if any of the following variables have an abnormal value in serum: sodium, potassium, calcium, chloride, bicarbonate, creatinine, or the glomerular filtrate rate calculated with the MDRD formula and the CKD-EPI formula.
21 secondary outcomes
Serum sodium concentration
Time frame: 3 hours to 7 days after laxative intake
Serum potasium concentration
Time frame: 3 hours to 7 days after laxative intake
Serum ionized calcium concentration
Time frame: 3 hours to 7 days after laxative intake
Serum chloride concentration
Time frame: 3 hours to 7 days after laxative intake
Serum bicarbonate concentration
Time frame: 3 hours to 7 days after laxative intake
Serum creatinine concentration
Time frame: 3 hours to 7 days after laxative intake
Glomerular filtration rate
Time frame: 3 hours to 7 days after laxative intake
Serum phosphorus concentration
Time frame: 3 hours to 7 days after laxative intake
Serum magnesium concentration
Time frame: 3 hours to 7 days after laxative intake
Blood pH
Time frame: 3 hours to 7 days after laxative intake
Hemoglobin concentration
Time frame: 3 hours to 7 days after laxative intake
Blood platelets
Time frame: 3 hours to 7 days after laxative intake
Adequate bowel cleansing for colonoscopy
Time frame: At the moment of colonoscopy
Adhrence to laxative intake
Time frame: 3-5 hours after laxative intake (at the colonoscopy appointment)
Time from last intake of laxative to the colonoscopy
Time frame: 3-5 hours after laxative intake (at the colonoscopy appointment)
Patient-reported experience measures (PREMs) questionnaire of laxative intake
Time frame: 3-5 hours after laxative intake (at the colonoscopy appointment)
Early side effects of laxative intake
Time frame: 3-5 hours after laxative intake (at the colonoscopy appointment)
Late side effects of laxative intake
Time frame: 3-7 days after laxative intake
Need of urgent consultation
Time frame: 3 hours to 7 days after laxative intake
Need for hospital admission
Time frame: 3 hours to 7 days after laxative intake
Need of any drug treatment, new treatment or modification, that may affect kidney function or serum electrolytes
Time frame: 3 hours to 7 days after laxative intake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco A Álvarez, MD, PhD principal investigator
Althaia Xarxa Assistencial Universitària de Manresa; Institut Hospital del Mar d'investigacions mèdiques, Barcelona.
Eduardo Albéniz, MD, PhD principal investigator
Hospital Universitario de Navarra; Navarrabiomed; UPNA; IdiSNA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Impairment and Adverse Effects of Medical Drugs, run by Marco Antonio Alvarez Gonzalez at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco A Álvarez, MD, PhD (0034 933160595, maalvarez@althaia.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global incidence of renal adverse effects (AEs) (time frame: 3 hours to 7 days after laxative intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023; AzTrials last refreshed its copy on 31 Oct 2026.