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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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)
Show all 11Show fewer
  • 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

Other trials in Belgium

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 groups in NCT02228551
Study groupRoleWhat they receive
ARC PPSOtherAugmented 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.

  1. 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)
  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.

  1. First posted29 Aug 2014 (estimated)
  2. Study startNov 2013
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

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)
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

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.

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