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Efficacy and safety of a balanced salt solution versus a 0.9% saline infusion for the prevention of contrast-induced acute kidney injury (BASIC trial): a study protocol for a randomized controlled trial.

ABSTRACT: Contrast-induced acute kidney injury (CI-AKI) is one of the most common causes of iatrogenic kidney injury and, therefore, its prevention is an important issue. However, whether the administration of 0.9% saline is the optimal prophylaxis method remains uncertain due to its supra-physiologic chloride component. In particular, recent studies suggest that chloride-restricted solutions showed superiority over 0.9% saline in several clinical settings.The investigators designed a multicenter randomized controlled trial to compare the efficacy of a balanced salt solution and 0.9% saline in CI-AKI prophylaxis. This study will recruit patients who are scheduled for contrast-enhanced computed tomography (CT) scans with CI-AKI prophylaxis. In this study, participants will be randomized into two study arms; the study group will receive a balanced salt solution, and the control group will receive 0.9% saline. Fluids will be administered as designated in the protocol before and after the CT scan, and an evaluation of baseline clinical status will be performed by obtaining blood and urine samples. During the follow-up visits, the incidence of CI-AKI and long-term outcomes, including the start of renal replacement therapy or all-cause mortality, will be assessed.To our knowledge, this study will be the first study assessing the preventive value of a balanced salt solution over 0.9% saline for CI-AKI. If the trial shows that the balanced salt solution is as effective for CI-AKI prophylaxis as 0.9% saline, the use of the balanced salt solution could be promoted due to the reduced possibility of consequent metabolic acidosis compared to 0.9% saline.ClinicalTrials.gov, ID: NCT02799368 . Registered on 14 June 2016.

SUBMITTER: Jo HA

PROVIDER: S-EPMC5629796 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Efficacy and safety of a balanced salt solution versus a 0.9% saline infusion for the prevention of contrast-induced acute kidney injury (BASIC trial): a study protocol for a randomized controlled trial.

Jo Hyung Ah HA Park Sehoon S Kim Chan-Duck CD Jung Hee-Yeon HY Cho Jang-Hee JH Cha Ran-Hui RH Kang Ea Wha EW Chang Tae Ik TI Kim Sejoong S Kim Hyung-Jong HJ Chung Byung Ha BH Lee Jung Pyo JP Park Jung Tak JT Han Seung Hyeok SH Yoo Tae-Hyun TH Ryu Dong-Ryeol DR Moon Sung Jin SJ Chang Jae Hyun JH Kim Dong Ki DK Joo Kwon Wook KW

Trials 20171005 1

<h4>Background</h4>Contrast-induced acute kidney injury (CI-AKI) is one of the most common causes of iatrogenic kidney injury and, therefore, its prevention is an important issue. However, whether the administration of 0.9% saline is the optimal prophylaxis method remains uncertain due to its supra-physiologic chloride component. In particular, recent studies suggest that chloride-restricted solutions showed superiority over 0.9% saline in several clinical settings.<h4>Methods/design</h4>The inv ...[more]

PMID: 28982378

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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:Intravenous fluids are used for almost all intensive care unit (ICU) patients. Clinical and laboratory studies have questioned whether specific fluid types result in improved outcomes, including mortality and acute kidney injury. To determine the effect of a balanced solution vs saline solution (0.9% sodium chloride) on 90-day survival in critically ill patients. Double-blind, factorial, randomized clinical trial conducted at 75 ICUs in Brazil. Patients who were admitted to the ICU with at least 1 risk factor for worse outcomes, who required at least 1 fluid expansion, and who were expected to remain in the ICU for more than 24 hours were randomized between May 29, 2017, and March 2, 2020; follow-up concluded on October 29, 2020. Patients were randomized to 2 different fluid types (a balanced solution vs saline solution reported in this article) and 2 different infusion rates (reported separately). Patients were randomly assigned 1:1 to receive either a balanced solution (n = 5522) or 0.9% saline solution (n = 5530) for all intravenous fluids. The primary outcome was 90-day survival. Among 11 052 patients who were randomized, 10 520 (95.2%) were available for the analysis (mean age, 61.1 [SD, 17] years; 44.2% were women). There was no significant interaction between the 2 interventions (fluid type and infusion speed; P = .98). Planned surgical admissions represented 48.4% of all patients. Of all the patients, 60.6% had hypotension or vasopressor use and 44.3% required mechanical ventilation at enrollment. Patients in both groups received a median of 1.5 L of fluid during the first day after enrollment. By day 90, 1381 of 5230 patients (26.4%) assigned to a balanced solution died vs 1439 of 5290 patients (27.2%) assigned to saline solution (adjusted hazard ratio, 0.97 [95% CI, 0.90-1.05]; P = .47). There were no unexpected treatment-related severe adverse events in either group. Among critically ill patients requiring fluid challenges, use of a balanced solution compared with 0.9% saline solution did not significantly reduce 90-day mortality. The findings do not support the use of this balanced solution. ClinicalTrials.gov Identifier: NCT02875873.

Project description:BackgroundPrevious study drew different conclusions on significant differences between saline and balanced crystalloid solution infused in critical illness but both showed a statistical difference in the sepsis subgroup. Thus, we will specifically focus on septic patients in this study to compare the effects of saline and balanced solution. We hypothesize that effects of saline on renal outcomes are related to the underline acute kidney injury (AKI) severity and total volumes of infusion.Methods/designThe investigators designed a pragmatic, multi-center parallel controlled trial recruiting 312 patients who are diagnosed with sepsis/septic shock in the intensive care unit (ICU) and will be assigned with either acetate Ringer's solution or saline in the corresponding month. Patients with an end-stage renal disease (ESRD) or who need renal replacement therapy (RRT) prior to or at the time of enrolment are excluded. Enrolled patients will be regarded as with mild, moderate, or severe sepsis on the basis of the severity of their illness and will be divided into subgroups according to their initial renal function and various intravenous infusion volumes when being analyzed. The primary outcome is major adverse kidney events within 28 days (MAKE28), including the composite of in-hospital death, receipt of new renal replacement therapy, or persistent renal dysfunction. Secondary outcomes include 28-day mortality, internal environment disturbance, incidence and duration of vasoactive drug treatment, duration of mechanical ventilation, duration of RRT, and ICU and hospital length of stay.Results and conclusionsTo our knowledge, this study will be the first to focus on septic patients and provide credible and evident data on the comparison of outcome between acetate Ringer's solution and saline for intravenous infusion in adult septic patients on the basis of baseline renal function and infusion volumes taken into consideration.Trial registrationClinicalTrials.gov NCT03685214 . Registered on August 15, 2018.

Project description:BACKGROUND:Infusion therapy is one of the most frequently prescribed medications in hospitalized patients. Currently used crystalloid solutes have a variable composition and may therefore influence acid-base status, intracellular and extracellular water content and plasma electrolyte compositions and have a major impact on organ function and outcome. The aim of our study was to investigate whether use of acetate-based balanced crystalloids leads to better hemodynamic stability compared to 0.9% saline. METHODS:We performed a sub-analysis of a prospective, randomized, controlled trial comparing effects of 0.9% saline or an acetate-buffered, balanced crystalloid during the perioperative period in patients with end-stage renal disease undergoing cadaveric renal transplantation. Need for catecholamine therapy and blood pressure were the primary measures. RESULTS:A total of 150 patients were included in the study of which 76 were randomized to 0.9% saline while 74 received an acetate-buffered balanced crystalloid. Noradrenaline for cardiocirculatory support during surgery was significantly more often administered in the normal saline group, given earlier and with a higher cumulative dose compared to patients receiving an acetate-buffered balanced crystalloid (30% versus 15%, p = 0.027; 68 ± 45 µg/kg versus 75 ± 60 µg/kg, p = 0.0055 and 0.000492?µg/kg body weight/min, ±0.002311 versus 0.000107?µg/kg/min, ±0.00039, p = 0.04, respectively). Mean minimum arterial blood pressure was significantly lower in patients randomized to 0.9% saline than in patients receiving the balanced infusion solution (57.2 [SD 8.7] versus 60.3 [SD 10.2] mm?Hg, p = 0.024). CONCLUSION:The use of an acetate-buffered, balanced infusion solution results in reduced need for use of catecholamines and cumulative catecholamine dose for hemodynamic support and in less occurrence of arterial hypotension in the perioperative period. Further research in the field is strongly encouraged.

Project description: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.

Dataset Information

Efficacy and safety of a balanced salt solution versus a 0.9% saline infusion for the prevention of contrast-induced acute kidney injury (BASIC trial): a study protocol for a randomized controlled trial.

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Efficacy and safety of a balanced salt solution versus a 0.9% saline infusion for the prevention of contrast-induced acute kidney injury (BASIC trial): a study protocol for a randomized controlled trial.

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