Postoperative Acute Kidney Injury in Patients Undergoing Prolonged Neurosurgical Operations
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|ClinicalTrials.gov Identifier: NCT03486184|
Recruitment Status : Not yet recruiting
First Posted : April 3, 2018
Last Update Posted : April 3, 2018
|Condition or disease||Intervention/treatment|
|Postoperative Acute Kidney Injury||Diagnostic Test: Cystatin-C|
- Postoperative acute kidney injury (AKI) is a highly prevalent and prognostically important complication in various surgical settings. Patients who developed postoperative AKI is independently associated with markedly increased morbidity, mortality1-8 and higher economic burden1.
- AKI was defined by an increase in serum creatinine (SCr) ≥ 0.3 mg/dl or by an increase in SCr ≥ 50% and/or by a decrease in urine output to 0.5 ml/kg/hour for 6 hours, in the first 48 hours after surgery.
- Patients who developed AKI had a higher total ICU costs, prolonged length of hospital and ICU stay, and longer duration of postoperative mechanical ventilation.
- AKI has been studied in different surgical procedures especially cardiac & abdominal surgeries.
- Kovacheva et al 2016 retrospective study included 1656 craniotomy patients from 1998 to 2011. The AKI used criteria was RIFLE (Risk, Injury, Failure, Loss of kidney function and End-Stage Renal Failure), they reported an incidence of 9.9% of postoperative AKI9.
- Deng et al 2017 also reported an incidence of AKI up to 13.5% in patients undergoing neurosurgical surgery within the first 7 days. It was associated with independent risk factors included intraoperative blood loss, postoperative reoperation, use of mannitol during operation, concentration of Cystatin-C; a biomarker protein detecting early kidney injury before creatinine changes and postoperative APACHE II score10.
- As the number of neurosurgical procedures has been increased worldwide and in our department as well with new types of prolonged neurosurgery e.g. Skull - Base - Major cerebrovascular beside major cranial tumor excision. It becomes a necessary to re-evaluate the incidence, factors behind AKI and outcome in such prolonged surgery.
- In 2002, The Acute Dialysis Quality Initiative (ADQI) was created with primary goal was to create a uniform, accepted definition of AKI; hence RIFLE criteria was born. RIFLE is an acronym of Risk, Injury, Failure, Loss of Kidney Function & End-Stage Kidney Failure.
- In 2004, The Acute Kidney Injury Network (AKIN) was formed. A report of the AKIN proposed the following criteria for AKI.
- The AKIN criteria differ from the RIFLE criteria in several ways. The RIFLE criteria are defined as changes within 7 days, while the AKIN criteria suggest using 48 hours. The AKIN classification includes less severe injury in the criteria and AKIN also avoids using the glomerular filtration rate as a marker in AKI, as there is no dependable way to measure glomerular filtration rate and estimated glomerular filtration rate are unreliable in AKI.
- Haase et al. 2009 in their comparative study between RIFLE and AKIN in cardiac surgery; found no difference between the AKI scores11.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||2 Days|
|Official Title:||Postoperative Acute Kidney Injury in Patients Undergoing Prolonged Neurosurgical Operations|
|Estimated Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||April 30, 2020|
- Diagnostic Test: Cystatin-C
- Laboratory values will be obtained, including level of preoperative serum creatinine, complete blood count, coagulation profile and Cystatin-C (5 ml. venous sample).
- Serum creatinine and hemoglobin will be measured after operation, and thereafter at least once a day as a part of routine clinical care. Postoperative serum Cystatin-C will measured only once.
- the occurrence of AKI [ Time Frame: 2 days ]BY using AKIN criteria.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486184
|Contact: Ali M Abdel-Salam, Master||+2 email@example.com|