Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05030727 |
| Other study ID # |
09.2021.392 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 5, 2021 |
| Est. completion date |
September 10, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Marmara University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to detect early renal dysfunction that may occur during the surgical
procedure in geriatric patients who will undergo laparotomy surgery.
In elderly patients undergoing surgery, accurate estimation of organ function is often not
possible. Accurate measurement of kidney function is vital to the routine care of patients.
Determining kidney function status can predict the progression of kidney disease and prevent
toxic drug levels in the body.The biochemical marker creatinine, found in serum and urine, is
widely used in the estimation of GFR. Although glomerular filtration rate decreases with
aging, creatinine also decreases in the elderly due to muscle loss. Even moderately elevated
blood creatinine may be indicative of severe kidney failure. Creatinine clearance (CrCl) is
the volume of blood plasma cleared of creatinine per unit time. It is a fast and
cost-effective method for measuring kidney function. Creatine is a breakdown product of
creatine phosphate found in skeletal muscle. Its production in the body depends on muscle
mass. The CrCl ratio approximates the GFR calculation as it freely filters the glomerular
creatine.
High serum creatinine levels and decreased CrCl ratio are usually indicators of abnormal
kidney function.One of the markers of acute kidney injury is to look at plasma NGAL values.
Plasma NGAL (neutrophil gelatinase associated lipocalin) increases in response to damaged
kidney status and can predict acute kidney injury as an early marker. Data on investigating
plasma NGAL values as a predictive biomarker of acute kidney injury in patients undergoing
non-cardiovascular surgery are very limited NGAL is produced from the epithelium of kidneys,
lungs, colon, liver, adipose tissue, and inflammatory cells. NGAL is elevated in serum and
urine after acute tubular injury, making it possible to diagnose kidney damage within 2 hours
of injury. However, the increase of other traditional markers such as creatinine may be
delayed for up to 48 hours after acute kidney injury.To determine the roles of primary
outcome serum creatinine, creatinine clearance rates and plasma NGAL levels in the diagnosis
of acute renal failure
Description:
This study will be performed on 60 patients aged 64 years and older who will undergo major
abdominal laparotomy surgery in Marmara University Pendik E.A.H Operating Room, whose
informed consent forms have been obtained from the patients. Patients with severe cardiac and
respiratory distress, liver and kidney failure, and those who did not consent to the study
will not be accepted into the study.
Preoperative (0.hour baseline), postoperative 24.,48. BUN, Creatinine, Lactate values in the
blood of the patients at 1 hour, and for plasma NGAL, blood samples will be taken at the
preoperative, postoperative 6th and 24th hours. And the results will be recorded.
No group will be formed in the study, which includes a total of 60 patients. All patients
will be anesthetized by induction of anesthesia (2 mg/kg propfol/ 1-2 mcgr/kg remifentanil/
0.6 mg/kg rocuronium), and intraoperative inhaler Desflurane + intravenous Remifentanil will
be used to provide maintenance anesthesia. Patients will be given intravenous fluids of 4-8
ml/kg/hr with PVI monitoring, if necessary, without fluid restriction.
Statistically is acceptable for the area under the ROC curve to be above 0.700. It has been
determined that we need a minimum of 60 people in order to show that an area with a minimum
level of 0.700 is statistically significant.
the aim of our study is to detect early renal dysfunction that may occur during the surgical
procedure in geriatric patients who will undergo laparotomy surgery.
In elderly patients undergoing surgery, accurate estimation of organ function is often not
possible. Accurate measurement of kidney function is vital to the routine care of patients.
Determining kidney function status can predict the progression of kidney disease and prevent
toxic drug levels in the body. Glomerular filtration rate measurement includes the injection
of inulin and its clearance by the kidneys. However, the use of inulin is invasive, time
consuming and an expensive procedure. Alternatively, the biochemical marker creatinine, found
in serum and urine, is widely used in the estimation of GFR. Although glomerular filtration
rate decreases with aging, creatinine also decreases in the elderly due to muscle loss. Even
moderately elevated blood creatinine may be indicative of severe kidney failure. Creatinine
clearance (CrCl) is the volume of blood plasma cleared of creatinine per unit time. It is a
fast and cost-effective method for measuring kidney function. Creatine is a breakdown product
of creatine phosphate found in skeletal muscle. Its production in the body depends on muscle
mass. The CrCl ratio approximates the GFR calculation as it freely filters the glomerular
creatinine. However, it is also secreted by the peritubular capillaries, causing CrCl to
overestimate GFR by about 10% to 20%. Despite the marginal error, it was an accepted method
for measuring GFR due to the ease of measurement of CrCl. Creatinine clearance can be
estimated using serum creatinine levels. The Cockcroft-Gault (C-G) formula uses the patient's
weight (kg) and gender to estimate CrCl (mg/dL). To correct for lower CrCl in females, the
resulting CrCl is multiplied by 0.85 if the patient is female. The C-G formula is age
dependent as the main predictor for CrCl.
eCCr = (140 - age) x (kg) x [0.85 if female] / 72 x [Serum creatinine (mg/dL)] High serum
creatinine levels and decreased CrCl ratio are usually indicators of abnormal kidney
function.
One of the markers of acute kidney injury is to look at plasma NGAL values. Plasma NGAL
(neutrophil gelatinase associated lipocalin) increases in response to damaged kidney status
and can predict acute kidney injury as an early marker. Data on investigating plasma NGAL
values as a predictive biomarker of acute kidney injury in patients undergoing
non-cardiovascular surgery are very limited NGAL is produced from the epithelium of kidneys,
lungs, colon, liver, adipose tissue, and inflammatory cells. NGAL is elevated in serum and
urine after acute tubular injury, making it possible to diagnose kidney damage within 2 hours
of injury. However, the increase of other traditional markers such as creatinine may be
delayed for up to 48 hours after acute kidney injury.
To determine the roles of primary outcome serum creatinine, creatinine clearance rates and
plasma NGAL levels in the diagnosis of acute renal failure
