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0.9% saline versus Plasma-Lyte as initial fluid in children with diabetic ketoacidosis (SPinK trial): a double-blind randomized controlled trial

Critical care (London, England), 2020-01, Vol.24 (1), p.1-1, Article 1 [Peer Reviewed Journal]

COPYRIGHT 2020 BioMed Central Ltd. ;2020. This work is licensed under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;The Author(s). 2020 ;ISSN: 1364-8535 ;EISSN: 1466-609X ;DOI: 10.1186/s13054-019-2683-3 ;PMID: 31898531

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Title:
0.9% saline versus Plasma-Lyte as initial fluid in children with diabetic ketoacidosis (SPinK trial): a double-blind randomized controlled trial
Author: Williams, Vijai ; Jayashree, Muralidharan ; Nallasamy, Karthi ; Dayal, Devi ; Rawat, Amit
Subjects: Acute Kidney Injury - drug therapy ; Acute Kidney Injury - prevention & control ; Blood pressure ; Carbonates ; Care and treatment ; Cerebral edema ; Child ; Child, Preschool ; Children ; Chloride ; Clinical trials ; Diabetes ; Diabetic ketoacidosis ; Diabetic Ketoacidosis - drug therapy ; Diseases ; Double-Blind Method ; Edema ; Emergency medical care ; Equipment and supplies ; Female ; Fluid therapy ; Fluids ; Gluconates - standards ; Gluconates - therapeutic use ; Humans ; India ; Insulin ; Intensive care ; Ketoacidosis ; Magnesium Chloride - standards ; Magnesium Chloride - therapeutic use ; Male ; Mortality ; Patient outcomes ; Pediatric ; Pediatric Emergency Medicine - methods ; Pediatric research ; Pediatrics ; Plasma ; Potassium Chloride - standards ; Potassium Chloride - therapeutic use ; Proportional Hazards Models ; Prospective Studies ; Saline ; Saline solution ; Saline Solution - standards ; Saline Solution - therapeutic use ; Sepsis ; Septic shock ; Shock ; Sodium Acetate - standards ; Sodium Acetate - therapeutic use ; Sodium Chloride - standards ; Sodium Chloride - therapeutic use ; Survival analysis ; Teachers ; Testing ; Time ; Values
Is Part Of: Critical care (London, England), 2020-01, Vol.24 (1), p.1-1, Article 1
Description: Acute kidney injury (AKI) is an important complication encountered during the course of diabetic ketoacidosis (DKA). Plasma-Lyte with lower chloride concentration than saline has been shown to be associated with reduced incidence of AKI in adults with septic shock. No study has compared this in DKA. This double-blind, parallel-arm, investigator-initiated, randomized controlled trial compared 0.9% saline with Plasma-Lyte-A as initial fluid in pediatric DKA. The study was done in a tertiary care, teaching, and referral hospital in India in children (> 1 month-12 years) with DKA as defined by ISPAD. Children with cerebral edema or known chronic kidney/liver disease or who had received pre-referral fluids and/or insulin were excluded. Sixty-six children were randomized to receive either Plasma-Lyte (n = 34) or 0.9% saline (n = 32). Primary outcome was incidence of new or progressive AKI, defined as a composite outcome of change in creatinine (defined by KDIGO), estimated creatinine clearance (defined by p-RIFLE), and NGAL levels. The secondary outcomes were resolution of AKI, time to resolution of DKA (pH > 7.3, bicarbonate> 15 mEq/L & normal sensorium), change in chloride, pH and bicarbonate levels, proportion of in-hospital all-cause mortality, need for renal replacement therapy (RRT), and length of ICU and hospital stay. Baseline characteristics were similar in both groups. The incidence of new or progressive AKI was similar in both [Plasma-Lyte 13 (38.2%) versus 0.9% saline 15 (46.9%); adjusted OR 1.22; 95% CI 0.43-3.43, p = 0.70]. The median (IQR) time to resolution of DKA in Plasma-Lyte-A and 0.9% saline were 14.5 (12 to 20) and 16 (8 to 20) h respectively. Time to resolution of AKI was similar in both [Plasma-Lyte 22.1 versus 0.9% saline 18.8 h (adjusted HR 1.72; 95% CI 0.83-3.57; p = 0.14)]. Length of hospital stay was also similar in both [Plasma-Lyte 9 (8 to 12) versus 0.9% saline 10 (8.25 to 11) days; p = 0.39]. The incidence of new or progressive AKI and resolution of AKI were similar in both groups. Plasma-Lyte-A was similar to 0.9% Saline in time to resolution of DKA, need for RRT, mortality, and lengths of PICU and hospital stay. Clinical trial registry of India, CTRI/2018/05/014042 (ctri.nic.in) (Retrospectively registered).
Publisher: England: BioMed Central Ltd
Language: English
Identifier: ISSN: 1364-8535
EISSN: 1466-609X
DOI: 10.1186/s13054-019-2683-3
PMID: 31898531
Source: MEDLINE
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0.9% saline versus Plasma-Lyte as initial fluid in children with diabetic ketoacidosis (SPinK trial): a double-blind randomized controlled trial

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