Acute Kidney Injury After Craniocerebral Operation
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|ClinicalTrials.gov Identifier: NCT03789747|
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment|
|Epidemiology Acute Kidney Injury Risk Factor||Other: As a observational study, there is no intervention.|
The study included consecutive adult patients who underwent craniotomy and admitted into intensive care unit (ICU) between January 2017 and December 2018. Patients with congenital renal abnormalities or with stages 4 and 5 chronic kidney disease (CKD) were excluded. Serum creatinine levels were measured before operation, daily after operation until discharged from ICU ward . AKI was depicted according to changes in early postoperative serum creatinine levels and its severity was determined based on the Acute Kidney Injury Network (AKIN) classification. Univariate and multivariate statistical analyses were conducted to determine risk factors for developing AKI.
Preoperative, intraoperative and postoperative variables known to be or could potentially be associated with AKI or other adverse outcomes were collected. Preoperation variables include age, gender, weight, hypertension, diabetes mellitus, hyperuricemia, proteinuria, preoperative serum Cr and estimated estimated glomerular filtration rate (eGFR), left ventricular ejection fraction (LVEF), Charlson Comorbidity Index (CCI), emergency surgery and intravenous contrast. eGFR was calculated with MDRD4 equation. Proteinuria was defined as protein > 15 mg/dl in spot urine specimens. Hyperuricemia was defined as a serum uric acid > 6.6 in women and > 7.0 mg/dl in men. Patients were considered to have diabetes if they were diagnosed with type 1 or type 2 diabetes mellitus before or were taking insulin or oral hypoglycemic agents at the time of cardiac surgery. Hypertension was defined as SBP > 140 mm Hg and/or DBP > 90 mm Hg; or had hypertension history and were taking antihypertensive drugs. LVEF was assessed preoperatively by echocardiography. Charlson Comorbidity Index was used to measure comorbid disease status by calculating the comorbidity score.
Intra-operative variables include surgery type, duration of operation, blood transfusion, urine output,the highest and lowest mean blood pressures, use of radiocontrast agents and dehydrants.
Postoperation variables include hypotension, central venous pressure (CVP), oliguria, re-exploration, mechanical ventilation, use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACEI/ARB), radiocontrast agents, dehydrants and RRT. Hypotension was defined as SBP < 90 mm Hg postoperative but before the diagnosis of AKI.
Patients were followed until discharge and all-cause in-hospital mortality was recorded. The length of stay in the ICU and hospital was also recorded. The mortality rates of the patients with or without AKI were compared.
Continuous variables were expressed as mean (SD) and analyzed by unpaired Student's t test. Nonparametric variables were expressed as median and 25-75% percentiles and analyzed by the Mann-Whitney test. Categorical variables were expressed as absolute (n) and relative (%) frequency and were analyzed by chi-square test, as appropriate. A multivariate logistic regression model incorporating all factors associated with AKI in univariate analysis as well as those factors showing a univariate p value < 0.05 was performed to identify associated risk factors with AKI, while Cox Proportional Hazards model was used to identify associated factors with in-hospital mortality and hazard ratios. Risk data are presented as odds or hazard ratios with 95% CIs. p < 0.05 was considered statistically significant for all comparisons. SPSS version 19.0 for windows software was used for the statistical analysis.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Incidence and Risk Factors of Acute Kidney Injury After Craniocerebral Operation: A Single-Center Experience|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
- Other: As a observational study, there is no intervention.
As a observational study, there is no intervention.
- Incidence and outcome of AKI after Craniotomy [ Time Frame: 1 month ]All adult patients who underwent craniotomy and admitted into intensive care unit (ICU) between January 2017 and December 2018 were screened for acute kidney injury.
- Risk factors for AKI after Craniotomy [ Time Frame: 1 month ]Preoperative, intraoperative and postoperative variables known to be or could potentially be associated with AKI or other adverse outcomes were collected. A multivariate logistic regression model incorporating all factors associated with AKI in univariate analysis as well as those factors showing a univariate p value < 0.05 was performed to identify associated risk factors with AKI.
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): NCT03789747
|Contact: Jianfang Zhou, MDemail@example.com|
|Beijing Tian Tan hospital||Recruiting|
|Beijing, Beijing, China, 100050|
|Contact: Jianfang Zhou, MD 8610-59976518 firstname.lastname@example.org|
|Study Director:||Jianxin Zhou, MD||Beijing Tian Tan Hospital|
|Study Director:||Guangzhi Shi, MD||Beijing Tian Tan Hospital|