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

Hyung Ah Jo, Sehoon Park, Chan Duck Kim, Hee Yeon Jung, Jang Hee Cho, Ran hui Cha, Ea Wha Kang, Tae Ik Chang, Sejoong Kim, Hyung Jong Kim, Byung Ha Chung, Jung Pyo Lee, Jung Tak Park, SeungHyeok Han, TaeHyun Yoo, Dong Ryeol Ryu, Sung Jin Moon, Jae Hyun Chang, Dong Ki Kim, Kwon Wook Joo

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background: 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. Methods/design: 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. Discussion: 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. Trials registration: ClinicalTrials.gov, ID: NCT02799368. Registered on 14 June 2016.

Original languageEnglish
Article number461
JournalTrials
Volume18
Issue number1
DOIs
Publication statusPublished - 2017 Oct 5

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Acute Kidney Injury
Randomized Controlled Trials
Salts
Safety
Chlorides
Tomography
Renal Replacement Therapy
Acidosis
Sodium Chloride
Research Personnel
Urine
Kidney
Control Groups
Mortality
Incidence
Wounds and Injuries

All Science Journal Classification (ASJC) codes

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Jo, Hyung Ah ; Park, Sehoon ; Kim, Chan Duck ; Jung, Hee Yeon ; Cho, Jang Hee ; Cha, Ran hui ; Kang, Ea Wha ; Chang, Tae Ik ; Kim, Sejoong ; Kim, Hyung Jong ; Chung, Byung Ha ; Lee, Jung Pyo ; Park, Jung Tak ; Han, SeungHyeok ; Yoo, TaeHyun ; Ryu, Dong Ryeol ; Moon, Sung Jin ; Chang, Jae Hyun ; Kim, Dong Ki ; Joo, Kwon Wook. / 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. In: Trials. 2017 ; Vol. 18, No. 1.
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title = "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 = "Background: 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. Methods/design: 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. Discussion: 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. Trials registration: ClinicalTrials.gov, ID: NCT02799368. Registered on 14 June 2016.",
author = "Jo, {Hyung Ah} and Sehoon Park and Kim, {Chan Duck} and Jung, {Hee Yeon} and Cho, {Jang Hee} and Cha, {Ran hui} and Kang, {Ea Wha} and Chang, {Tae Ik} and Sejoong Kim and Kim, {Hyung Jong} and Chung, {Byung Ha} and Lee, {Jung Pyo} and Park, {Jung Tak} and SeungHyeok Han and TaeHyun Yoo and Ryu, {Dong Ryeol} and Moon, {Sung Jin} and Chang, {Jae Hyun} and Kim, {Dong Ki} and Joo, {Kwon Wook}",
year = "2017",
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doi = "10.1186/s13063-017-2202-2",
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Jo, HA, Park, S, Kim, CD, Jung, HY, Cho, JH, Cha, RH, Kang, EW, Chang, TI, Kim, S, Kim, HJ, Chung, BH, Lee, JP, Park, JT, Han, S, Yoo, T, Ryu, DR, Moon, SJ, Chang, JH, Kim, DK & Joo, KW 2017, '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', Trials, vol. 18, no. 1, 461. https://doi.org/10.1186/s13063-017-2202-2

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; Park, Sehoon; Kim, Chan Duck; Jung, Hee Yeon; Cho, Jang Hee; Cha, Ran hui; Kang, Ea Wha; Chang, Tae Ik; Kim, Sejoong; Kim, Hyung Jong; Chung, Byung Ha; Lee, Jung Pyo; Park, Jung Tak; Han, SeungHyeok; Yoo, TaeHyun; Ryu, Dong Ryeol; Moon, Sung Jin; Chang, Jae Hyun; Kim, Dong Ki; Joo, Kwon Wook.

In: Trials, Vol. 18, No. 1, 461, 05.10.2017.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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)

T2 - A study protocol for a randomized controlled trial

AU - Jo, Hyung Ah

AU - Park, Sehoon

AU - Kim, Chan Duck

AU - Jung, Hee Yeon

AU - Cho, Jang Hee

AU - Cha, Ran hui

AU - Kang, Ea Wha

AU - Chang, Tae Ik

AU - Kim, Sejoong

AU - Kim, Hyung Jong

AU - Chung, Byung Ha

AU - Lee, Jung Pyo

AU - Park, Jung Tak

AU - Han, SeungHyeok

AU - Yoo, TaeHyun

AU - Ryu, Dong Ryeol

AU - Moon, Sung Jin

AU - Chang, Jae Hyun

AU - Kim, Dong Ki

AU - Joo, Kwon Wook

PY - 2017/10/5

Y1 - 2017/10/5

N2 - Background: 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. Methods/design: 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. Discussion: 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. Trials registration: ClinicalTrials.gov, ID: NCT02799368. Registered on 14 June 2016.

AB - Background: 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. Methods/design: 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. Discussion: 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. Trials registration: ClinicalTrials.gov, ID: NCT02799368. Registered on 14 June 2016.

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DO - 10.1186/s13063-017-2202-2

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JO - Trials

JF - Trials

SN - 1745-6215

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