Prevalence of Augmented Renal ClearanceARCPPSNCT02228551
Augmented Renal Clearance in the Adult Non-critically Ill Surgery Patient: a Prospective Point Prevalance Study
A study testing Augmented renal clearance Point prevalence study in people with Prevalence of Augmented Renal Clearance and Risk Factors for Augmented Renal Clearance, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This point prevalence study investigates the prevalence of augmented renal clearance (i.e. a measured 8-hour urinary creatinine clearance >= 120 ml/min/1.73m²) in an adult non-critically ill abdominal and trauma surgery population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevalence of Augmented Renal Clearance, Risk Factors for Augmented Renal Clearance
- What is being tested?
- Augmented renal clearance Point prevalence study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2013to May 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On the recruitment days, all non-critically ill adult patients hospitalized at the 74-bed abdominal and 50-bed trauma surgery wards in the 1850-bed University Hospitals Leuven were eligible for inclusion. On both wards, urinary collections are not routinely performed as part of standard of care.
Who cannot join
- Do not resuscitate (DNR) code ≥ 2
- Discharge before 16 hour on the day of collection (d0)
- Surgery on the day of collection Pregnancy, lactation
- Renal replacement therapy
- Non-Caucasian ethnicity
- Isolation in order for source control due to infection with multi-drug resistant organisms (MDRO)
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- Incontinence or the lack of cooperation
- At the abdominal ward in particular
- Women without an indwelling urinary catheter were also excluded due to the incapacity of these patients to carry out the urinary collection in a safe and painless manner
- During the urinary collection, patients with incomplete or doubtful urinary collections were excluded
- Patients could only be included once, except for those with incomplete urinary collection at an earlier day of collection.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Abdominal surgery ward and Trauma surgery ward, University Hospitals Leuven
Leuven, Vlaams Brabant, 3000
About this study
Official title: Augmented Renal Clearance in the Adult Non-critically Ill Surgery Patient: a Prospective Point Prevalance Study and Identification of Risk Factors
This point prevalence study investigates the prevalence of augmented renal clearance (i.e. a measured 8-hour urinary creatinine clearance >= 120 ml/min/1.73m²) in an adult non-critically ill abdominal and trauma surgery population. Secondary objectives are the identification of risk factors associated with ARC in this specific study population.
Read the detailed description
This point prevalence study investigates the prevalence of augmented renal clearance (i.e. a measured 8-hour urinary creatinine clearance >= 120 ml/min/1.73m²) in an adult non-critically ill abdominal and trauma surgery population.
Secondary objectives are the identification of risk factors associated with ARC in this specific study population.
In every included patient, an 8-hour urine collection was carried out over an 8-hour time period to determine the CrCl8h. Participants were asked to empty the bladder at the start of the collection. From then, patients were asked to collect urine in a recipient during the following 8 hours. If an indwelling transurethral or suprapubic urinary catheter was in situ, the collection bag was emptied at the start of the collection. After 8 hours, total urinary volumes (Uv8h) were measured with a measuring cup and urinary creatinine concentrations were determined by laboratory analysis (enzymatic analysis by Roche Diagnostics). Midterm serum creatinine samples were obtained at 4 hours after the start of the urinary collection. Based on these values, CrCl8h was calculated according to the standard formulas and normalized to a body surface area (BSA) of 1.73m².
The following demographic and clinical data were prospectively recorded or calculated: age, sex, total body weight, lean body weight, length, BMI, BSA, presence of an urinary catheter, pre- or postoperative status, 'preoperative American society of anesthesiology' (ASA) score, relevant medical history with respect to the kidney function or SCr levels (i.e. arterial hypertension, chronic kidney disease, diabetes mellitus, paralyzed patients or patients with amputated limb(s)), length of stay (LOS) since admission in the hospital until the day of collection (LOShosp), since admission on the ward until the day of collection (LOSward), since surgery until the day of collection (LOSsurgery), LOS in the hospital at discharge (LOSdisch), number of surgical interventions since admission until the day of collection, the mean daily volume of administered fluids based on the 3 days before the day of collection (d-3, d-2, d-1) as well as on the day of collection (d0), the relevant co-medication during d-3, d-2 and d-1 as well as d0, number of patients with one or more postoperative complication(s) (POC), number of POCs per patient and the highest severity grade of POCs per patient, C-reactive protein concentration (CRP) and white blood cell count (WBC) on d-1 or d0, baseline SCr (i.e. a SCr value from maximum 1 year old collected during a consultation), preoperative SCr (i.e. first SCr during hospital stay but before any surgical procedure) and SCr at discharge from the hospital. From the surgical procedure closest to the day of collection, we collected duration of anesthesia and surgical procedure, the administration of vasopressor agents, the volume and type of resuscitation fluids administered during surgery (i.e. crystalloids, colloids or blood derivates) and volumes of urine and blood loss. Additionally, in abdominal surgery patients, following demographic data were collected: elective or emergency surgical procedure, presence of a nasogastric tube and an ileo- or colostoma on the day of collection, reason for admission (i.e. colorectal, hepatobiliary or other), whether there was an oncologic indication for surgery and laparoscopic or open surgery. In trauma surgery patients following demographic data were collected additionally: the injury severity score (ISS) on admission, diagnosis at admission (i.e. trauma with fracture, trauma without fracture, infection, removal of osteosynthesis material or other) and type of fracture (if trauma with fracture). The type and severity of postoperative complications were classified using the Clavien-Dindo classification. All data were retrieved from the patient's computerized medical files and were registered in a patient study file (appendix 9.3) and in a Microsoft Office Access 2007 database.
- Being tested
- Augmented renal clearance Point prevalence study
- Keywords
- Augmented renal clearance, non-critically ill, surgery, prevalence, risk factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented renal clearance Point prevalence studyOther
An 8-hour urine collection was carried out to determine the CrCl8h. Participants were asked to empty the bladder at the start of the collection. From then, patients were asked to collect urine in a recipient during the following 8 hours. If an indwelling transurethral or suprapubic urinary catheter was in situ, the collection bag was emptied at the start of the collection. After 8 hours, total urinary volumes (Uv8h) were measured with a measuring cup and urinary creatinine concentrations were determined by laboratory analysis. Midterm serum creatinine samples were obtained at 4 hours after the start of the urinary collection. Based on these values, CrCl8h was calculated according to the standard formulas and normalized to a body surface area (BSA) of 1.73m².
| Study group | Role | What they receive |
|---|---|---|
| ARC PPS | Other | Augmented renal clearance Point prevalence study Receives: Other: Augmented renal clearance Point prevalence study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of augmented renal clearance
The prevalence of augmented renal clearance was calculated as the number of patients demonstrating a measured urinary creatinine clearnace ≥ 120 mL/min/1.73m² divided by the total number of included patients.
Measured: 8 hours
Secondary outcomes (1)
Demographic and clinical factors independantly associated with augmented renal clearance
Demographic data, pre- or postoperative status, ASA score, relevant medical history with respect to the kidney function or SCr levels, interval from admission until the collection day, interval since surgery, LOS at discharge, number of surgical interventions, the mean daily volume of administered fluids based on the 3 days before the day of collection (d-3, d-2, d-1) as well as on the day of collection (d0), the relevant co-medication during d-3 until d0, patients with one or more postoperative complication (POC), number of POCs per patient and the highest severity grade of POCs per patient, CRP and white blood cell count (WBC) on d-1 or d0, baseline SCr, preoperative SCr and SCr at discharge from the hospital. From the surgical procedure closest to the day of collection, we collected duration of anesthesia and surgical procedure, the administration of vasopressor agents, the volume and type of resuscitation fluids administered during surgery and volumes of urine and blood loss.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevalence of Augmented Renal ClearanceStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Declercq, PharmD., Principal investigator, Pharmacy Department, University Hospitals Leuven & Department of Pharmaceutical and Pharmacological Sciences, KULeuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228551
- Sponsor's protocol ID
- S55822-S55712
- Acronym
- ARCPPS
- Status last verified
- Nov 2013
- First submitted
- 18 Jul 2014
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Renal Clearance in the Adult Non-critically Ill Surgery Patient: a Prospective Point Prevalance Study and Identification of Risk Factors
- ClinicalTrials.gov ID
- NCT02228551
- Acronym / sponsor ID
- ARCPPS / S55822-S55712
- Keywords
- Augmented renal clearance, non-critically ill, surgery, prevalence, risk factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 29 Aug 2014 (estimated)
- 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.
This point prevalence study investigates the prevalence of augmented renal clearance (i.e. a measured 8-hour urinary creatinine clearance >= 120 ml/min/1.73m²) in an adult non-critically ill abdominal and trauma surgery population. Secondary objectives are the identification of risk factors associated with ARC in this specific study population.
Detailed description
This point prevalence study investigates the prevalence of augmented renal clearance (i.e. a measured 8-hour urinary creatinine clearance >= 120 ml/min/1.73m²) in an adult non-critically ill abdominal and trauma surgery population.
Secondary objectives are the identification of risk factors associated with ARC in this specific study population.
In every included patient, an 8-hour urine collection was carried out over an 8-hour time period to determine the CrCl8h. Participants were asked to empty the bladder at the start of the collection. From then, patients were asked to collect urine in a recipient during the following 8 hours. If an indwelling transurethral or suprapubic urinary catheter was in situ, the collection bag was emptied at the start of the collection. After 8 hours, total urinary volumes (Uv8h) were measured with a measuring cup and urinary creatinine concentrations were determined by laboratory analysis (enzymatic analysis by Roche Diagnostics). Midterm serum creatinine samples were obtained at 4 hours after the start of the urinary collection. Based on these values, CrCl8h was calculated according to the standard formulas and normalized to a body surface area (BSA) of 1.73m².
The following demographic and clinical data were prospectively recorded or calculated: age, sex, total body weight, lean body weight, length, BMI, BSA, presence of an urinary catheter, pre- or postoperative status, 'preoperative American society of anesthesiology' (ASA) score, relevant medical history with respect to the kidney function or SCr levels (i.e. arterial hypertension, chronic kidney disease, diabetes mellitus, paralyzed patients or patients with amputated limb(s)), length of stay (LOS) since admission in the hospital until the day of collection (LOShosp), since admission on the ward until the day of collection (LOSward), since surgery until the day of collection (LOSsurgery), LOS in the hospital at discharge (LOSdisch), number of surgical interventions since admission until the day of collection, the mean daily volume of administered fluids based on the 3 days before the day of collection (d-3, d-2, d-1) as well as on the day of collection (d0), the relevant co-medication during d-3, d-2 and d-1 as well as d0, number of patients with one or more postoperative complication(s) (POC), number of POCs per patient and the highest severity grade of POCs per patient, C-reactive protein concentration (CRP) and white blood cell count (WBC) on d-1 or d0, baseline SCr (i.e. a SCr value from maximum 1 year old collected during a consultation), preoperative SCr (i.e. first SCr during hospital stay but before any surgical procedure) and SCr at discharge from the hospital. From the surgical procedure closest to the day of collection, we collected duration of anesthesia and surgical procedure, the administration of vasopressor agents, the volume and type of resuscitation fluids administered during surgery (i.e. crystalloids, colloids or blood derivates) and volumes of urine and blood loss. Additionally, in abdominal surgery patients, following demographic data were collected: elective or emergency surgical procedure, presence of a nasogastric tube and an ileo- or colostoma on the day of collection, reason for admission (i.e. colorectal, hepatobiliary or other), whether there was an oncologic indication for surgery and laparoscopic or open surgery. In trauma surgery patients following demographic data were collected additionally: the injury severity score (ISS) on admission, diagnosis at admission (i.e. trauma with fracture, trauma without fracture, infection, removal of osteosynthesis material or other) and type of fracture (if trauma with fracture). The type and severity of postoperative complications were classified using the Clavien-Dindo classification. All data were retrieved from the patient's computerized medical files and were registered in a patient study file (appendix 9.3) and in a Microsoft Office Access 2007 database.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARC PPS | Other | Other: Augmented renal clearance Point prevalence studyAugmented renal clearance Point prevalence study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- On the recruitment days, all non-critically ill adult patients hospitalized at the 74-bed abdominal and 50-bed trauma surgery wards in the 1850-bed University Hospitals Leuven were eligible for inclusion. On both wards, urinary collections are not routinely performed as part of standard of care.
Key exclusion criteria (11 listed)
- Do not resuscitate (DNR) code ≥ 2
- Discharge before 16 hour on the day of collection (d0)
- Surgery on the day of collection Pregnancy, lactation
- Renal replacement therapy
- Non-Caucasian ethnicity
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 |
|---|---|---|
| Augmented renal clearance Point prevalence studyAn 8-hour urine collection was carried out to determine the CrCl8h. Participants were asked to empty the bladder at the start of the collection. From then, patients were asked to collect urine in a recipient during the following 8 hours. If an indwelling transurethral or suprapubic urinary catheter was in situ, the collection bag was emptied at the start of the collection. After 8 hours, total urinary volumes (Uv8h) were measured with a measuring cup and urinary creatinine concentrations were determined by laboratory analysis. Midterm serum creatinine samples were obtained at 4 hours after the start of the urinary collection. Based on these values, CrCl8h was calculated according to the standard formulas and normalized to a body surface area (BSA) of 1.73m². | Other | ARC PPS |
Primary outcome
Prevalence of augmented renal clearance
Time frame: 8 hours
The prevalence of augmented renal clearance was calculated as the number of patients demonstrating a measured urinary creatinine clearnace ≥ 120 mL/min/1.73m² divided by the total number of included patients.
1 secondary outcome
Demographic and clinical factors independantly associated with augmented renal clearance
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
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.
Peter Declercq, PharmD. principal investigator
Pharmacy Department, University Hospitals Leuven & Department of Pharmaceutical and Pharmacological Sciences, KULeuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented renal clearance Point prevalence study in people with Prevalence of Augmented Renal Clearance and Risk Factors for Augmented Renal Clearance, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 inclusion and 11 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: finished, as of the sponsor's last update on 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of augmented renal clearance (time frame: 8 hours). 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 29 Aug 2014.