Prevalence of Augmented Renal Clearance Clinical Trial
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening