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Oral salt and water versus intravenous saline for the prevention of acute kidney injury following contrast-enhanced computed tomography: study protocol for a pilot randomized trial.

ABSTRACT: BACKGROUND:Although intravenous saline is the accepted prophylactic measure for the prevention of contrast- induced acute kidney injury, the oral route could offer an equivalent, practical, and cost saving approach. A systematic review of randomized trials that compared oral versus intravenous volume expansion for the prevention of radiocontrast-induced nephropathy in patients receiving arterial contrast reported no significant difference in the risk of contrast induced acute kidney injury between the oral and intravenous arms. Most trials for contrast nephropathy prevention have been in the setting of arterial contrast such as with cardiac catheterization, and not with venous contrast, such as computed tomography. The aim of this paper is to describe the protocol of a pilot trial comparing the effect of oral salt and water versus intravenous saline on the prevention of Acute Kidney Injury following contrast-enhanced computed tomography. METHODS:Our study is a pilot, single-centre parallel randomized controlled trial. To be included, participants must be at stage 4 of chronic kidney disease as defined by a glomerular filtration rate <30 mL/min/1.73 m(2), aged greater than 18 years and to undergo an outpatient contrast-enhanced computer tomography of the chest or abdomen. A total 50 patients will be randomised to receive either oral salt and water or intravenous isotonic saline. The primary outcome is feasibility, including estimates of recruitment rate, adherence to intervention and completeness of follow-up to assist in planning the definitive trial. The secondary outcome is safety and includes adverse events with oral salt and water loading as compared to intravenous isotonic saline. DISCUSSION:The results of this pilot trial will provide critical information to plan a definitive trial to test the efficacy of the route of volume loading regimens in prevention of acute kidney injury after contrast-enhanced CT scans. TRIAL REGISTRATION:The trial is registered at the US National Institutes of Health (ClinicalTrials.gov) # NCT02084771.

SUBMITTER: Swapnil H

PROVIDER: S-EPMC4399084 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Oral salt and water versus intravenous saline for the prevention of acute kidney injury following contrast-enhanced computed tomography: study protocol for a pilot randomized trial.

Swapnil Hiremath H Knoll Greg A GA Kayibanda Jeanne Françoise JF Fergusson Dean D Chow Benjamin Jw BJ Shabana Wael W Murphy Erin E Ramsay Tim T James Matthew M White Christine A CA Garg Amit A Wald Ron R Hoch Jeffrey J Akbari Ayub A

Canadian journal of kidney health and disease 20150416

<h4>Background</h4>Although intravenous saline is the accepted prophylactic measure for the prevention of contrast- induced acute kidney injury, the oral route could offer an equivalent, practical, and cost saving approach. A systematic review of randomized trials that compared oral versus intravenous volume expansion for the prevention of radiocontrast-induced nephropathy in patients receiving arterial contrast reported no significant difference in the risk of contrast induced acute kidney inju ...[more]

PMID: 25883789

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Project description:Rationale & Objective:We aimed to elucidate whether a balanced salt solution decreases the occurrence of contrast-induced acute kidney injury (CI-AKI) after contrast-enhanced computed tomography (CE-CT) as compared to 0.9% saline solution. Study Design:A randomized clinical trial. Setting & Participants:The study was performed in 14 tertiary hospitals in South Korea. Patients with estimated glomerular filtration rates (eGFRs) < 45 or <60 mL/min/1.73 m2 and additional risk factors (age ? 60 years or diabetes) who were undergoing scheduled CE-CT were included from December 2016 to December 2018. Intervention:An open-label intervention was performed. The study group received a balanced salt solution and the control group received 0.9% saline solution as prophylactic fluids for CE-CT. Outcomes:The primary outcome was CI-AKI, defined by creatinine level elevation ? 0.5 mg/dL or 25% from baseline within 48 to 72 hours after CE-CT. Secondary outcomes included AKI defined based on the KDIGO (Kidney Disease: Improving Global Outcomes) guideline, eGFR changes, death, or requiring dialysis within 6 months after CE-CT. Results:493 patients received the study fluids. The control and study groups included 251 and 242 patients, respectively. The occurrence of CI-AKI in the study (10 [4.2%]) and control (17 [6.8%]) groups was not significantly different (P = 0.27). No significant difference was present for the secondary outcomes; AKI by the KDIGO definition (study: 19 [7.9%], control: 27 [10.8%]; P = 0.33), death/dialysis (study: 11 [4.7%], control: 9 [3.7%]; P = 0.74), and eGFR changes (study: 0.1 ± 0.2 mg/dL, control: 0.3 ± 2.8 mg/dL; P = 0.69). Limitations:This study failed to meet target enrollment. Conclusions:The risk for CI-AKI was similar after administration of a balanced salt solution and after use of 0.9% saline solution during CE-CT in higher-risk patients. Funding:This study was funded by CJ Healthcare (CS2015_0046). Trial Registration:Registered at ClinicalTrials.gov with study number NCT02799368.

Project description:ObjectivesNon-contrast computed tomography (NCCT) markers are robust predictors of parenchymal hematoma expansion in intracerebral hemorrhage (ICH). We investigated whether NCCT features can also identify ICH patients at risk of intraventricular hemorrhage (IVH) growth.MethodsPatients with acute spontaneous ICH admitted at four tertiary centers in Germany and Italy were retrospectively included from January 2017 to June 2020. NCCT markers were rated by two investigators for heterogeneous density, hypodensity, black hole sign, swirl sign, blend sign, fluid level, island sign, satellite sign, and irregular shape. ICH and IVH volumes were semi-manually segmented. IVH growth was defined as IVH expansion > 1 mL (eIVH) or any delayed IVH (dIVH) on follow-up imaging. Predictors of eIVH and dIVH were explored with multivariable logistic regression. Hypothesized moderators and mediators were independently assessed in PROCESS macro models.ResultsA total of 731 patients were included, of whom 185 (25.31%) suffered from IVH growth, 130 (17.78%) had eIVH, and 55 (7.52%) had dIVH. Irregular shape was significantly associated with IVH growth (OR 1.68; 95%CI [1.16-2.44]; p = 0.006). In the subgroup analysis stratified by the IVH growth type, hypodensities were significantly associated with eIVH (OR 2.06; 95%CI [1.48-2.64]; p = 0.015), whereas irregular shape (OR 2.72; 95%CI [1.91-3.53]; p = 0.016) in dIVH. The association between NCCT markers and IVH growth was not mediated by parenchymal hematoma expansion.ConclusionsNCCT features identified ICH patients at a high risk of IVH growth. Our findings suggest the possibility to stratify the risk of IVH growth with baseline NCCT and might inform ongoing and future studies.Clinical relevance statementNon-contrast CT features identified ICH patients at a high risk of intraventricular hemorrhage growth with subtype-specific differences. Our findings may assist in the risk stratification of intraventricular hemorrhage growth with baseline CT and might inform ongoing and future clinical studies.Key points• NCCT features identified ICH patients at a high risk of IVH growth with subtype-specific differences. • The effect of NCCT features was not moderated by time and location or indirectly mediated by hematoma expansion. • Our findings may assist in the risk stratification of IVH growth with baseline NCCT and might inform ongoing and future studies.

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Oral salt and water versus intravenous saline for the prevention of acute kidney injury following contrast-enhanced computed tomography: study protocol for a pilot randomized trial.

Publications

Oral salt and water versus intravenous saline for the prevention of acute kidney injury following contrast-enhanced computed tomography: study protocol for a pilot randomized trial.

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