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Augmented Renal Clearance in the Adult Non-critically Ill Surgery Patient: a Prospective Point Prevalance Study (ARCPPS)

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ClinicalTrials.gov Identifier: NCT02228551
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief 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. Secondary objectives are the identification of risk factors associated with ARC in this specific study population.

Condition or disease Intervention/treatment Phase
Prevalence of Augmented Renal Clearance Risk Factors for Augmented Renal Clearance Other: Augmented renal clearance Point prevalence study Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 279 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Augmented Renal Clearance in the Adult Non-critically Ill Surgery Patient: a Prospective Point Prevalance Study and Identification of Risk Factors
Study Start Date : November 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
ARC PPS
Augmented renal clearance Point prevalence study
Other: Augmented renal clearance Point prevalence study
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Demographic and clinical factors independantly associated with augmented renal clearance [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Exclusion criteria were age younger than 18 years
  • 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)
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228551


Locations
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Belgium
Abdominal surgery ward and Trauma surgery ward, University Hospitals Leuven
Leuven, Vlaams Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Peter Declercq, PharmD. Pharmacy Department, University Hospitals Leuven & Department of Pharmaceutical and Pharmacological Sciences, KULeuven, Belgium

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02228551     History of Changes
Other Study ID Numbers: S55822-S55712
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: November 2013
Keywords provided by Universitaire Ziekenhuizen Leuven:
Augmented renal clearance
non-critically ill
surgery
prevalence
risk factors