The effects of 0.9% saline versus Plasma-Lyte 148 on renal function as assessed by creatinine concentration in patients undergoing major surgery: A single-centre double-blinded cluster crossover trial.

<h4>Objectives</h4>Saline and Plasma-Lyte have different physiochemical contents; consequently, they may differently affect patients' renal function. We compared the effects of fluid therapy with 0.9% saline and with Plasma-Lyte 148 on renal function as assessed by creatinine concen...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Laurence Weinberg, Michael Hua-Gen Li, Leonid Churilov, Christopher Macgregor, Kent Garrett, Jade Eyles, Rinaldo Bellomo
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/51cd684e9a81477095d104783328fc62
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:51cd684e9a81477095d104783328fc62
record_format	dspace
spelling	oai:doaj.org-article:51cd684e9a81477095d104783328fc622021-11-25T06:19:07ZThe effects of 0.9% saline versus Plasma-Lyte 148 on renal function as assessed by creatinine concentration in patients undergoing major surgery: A single-centre double-blinded cluster crossover trial.1932-620310.1371/journal.pone.0251718https://doaj.org/article/51cd684e9a81477095d104783328fc622021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0251718https://doaj.org/toc/1932-6203<h4>Objectives</h4>Saline and Plasma-Lyte have different physiochemical contents; consequently, they may differently affect patients' renal function. We compared the effects of fluid therapy with 0.9% saline and with Plasma-Lyte 148 on renal function as assessed by creatinine concentration among patients undergoing major surgery.<h4>Methods</h4>We conducted a prospective, double-blinded cluster crossover trial comparing the effects of the two fluids on major surgery patients. The primary aim was to establish the pilot feasibility, safety and preliminary efficacy evidence base for a large interventional trial to establish whether saline or Plasma-Lyte is the preferred crystalloid fluid for managing major surgery patients. The primary efficacy outcome was the proportion of patients with changes in renal function as assessed by creatinine concentration during their index hospital admission. We used changes in creatinine to define acute kidney injury (AKI) according to the RIFLE criteria.<h4>Results</h4>The study was feasible with 100% patient and clinician acceptance. There were no deviations from the trial protocol. After screening, we allocated 602 patients to saline and 458 to Plasma-Lyte. The median (IQR) volume of intraoperative fluid received was 2000 mL (1000:2000) in both groups. Forty-nine saline patients (8.1%) and 49 Plasma-Lyte patients (10.7%) developed a postoperative AKI (adjusted incidence rate ratio [aIRR]: 1.34; 95% CI: 0.93-1.95; p = 0.120). No differences were observed in the development of postoperative complications (aIRR: 0.98; 95% CI: 0.89-1.08) or the severity of the worst complication (aIRR: 1.00; 95% CI: 0.78-1.30). The median (IQR) length of hospital stay was six days (3:11) for the saline group and five days (3:10) for the Plasma-Lyte group (aIRR: 0.85; 95% CI: 0.73-0.98). There were no serious adverse events relating to the trial fluids, nor were there fluid crossover or contamination events.<h4>Conclusions</h4>The study design was feasible to support a future follow-up larger clinical trial. Patients treated with saline did not demonstrate an increased incidence of postoperative AKI (defined as changes in creatinine) compared to those treated with Plasma-Lyte. Our findings imply that clinicians can reasonably use either solution intraoperatively for adult patients undergoing major surgery.<h4>Trial registration</h4>Registry: Australian New Zealand Clinical Trials Registry; ACTRN12613001042730; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364988.Laurence WeinbergMichael Hua-Gen LiLeonid ChurilovChristopher MacgregorKent GarrettJade EylesRinaldo BellomoPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 5, p e0251718 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Laurence Weinberg Michael Hua-Gen Li Leonid Churilov Christopher Macgregor Kent Garrett Jade Eyles Rinaldo Bellomo The effects of 0.9% saline versus Plasma-Lyte 148 on renal function as assessed by creatinine concentration in patients undergoing major surgery: A single-centre double-blinded cluster crossover trial.
description	<h4>Objectives</h4>Saline and Plasma-Lyte have different physiochemical contents; consequently, they may differently affect patients' renal function. We compared the effects of fluid therapy with 0.9% saline and with Plasma-Lyte 148 on renal function as assessed by creatinine concentration among patients undergoing major surgery.<h4>Methods</h4>We conducted a prospective, double-blinded cluster crossover trial comparing the effects of the two fluids on major surgery patients. The primary aim was to establish the pilot feasibility, safety and preliminary efficacy evidence base for a large interventional trial to establish whether saline or Plasma-Lyte is the preferred crystalloid fluid for managing major surgery patients. The primary efficacy outcome was the proportion of patients with changes in renal function as assessed by creatinine concentration during their index hospital admission. We used changes in creatinine to define acute kidney injury (AKI) according to the RIFLE criteria.<h4>Results</h4>The study was feasible with 100% patient and clinician acceptance. There were no deviations from the trial protocol. After screening, we allocated 602 patients to saline and 458 to Plasma-Lyte. The median (IQR) volume of intraoperative fluid received was 2000 mL (1000:2000) in both groups. Forty-nine saline patients (8.1%) and 49 Plasma-Lyte patients (10.7%) developed a postoperative AKI (adjusted incidence rate ratio [aIRR]: 1.34; 95% CI: 0.93-1.95; p = 0.120). No differences were observed in the development of postoperative complications (aIRR: 0.98; 95% CI: 0.89-1.08) or the severity of the worst complication (aIRR: 1.00; 95% CI: 0.78-1.30). The median (IQR) length of hospital stay was six days (3:11) for the saline group and five days (3:10) for the Plasma-Lyte group (aIRR: 0.85; 95% CI: 0.73-0.98). There were no serious adverse events relating to the trial fluids, nor were there fluid crossover or contamination events.<h4>Conclusions</h4>The study design was feasible to support a future follow-up larger clinical trial. Patients treated with saline did not demonstrate an increased incidence of postoperative AKI (defined as changes in creatinine) compared to those treated with Plasma-Lyte. Our findings imply that clinicians can reasonably use either solution intraoperatively for adult patients undergoing major surgery.<h4>Trial registration</h4>Registry: Australian New Zealand Clinical Trials Registry; ACTRN12613001042730; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364988.
format	article
author	Laurence Weinberg Michael Hua-Gen Li Leonid Churilov Christopher Macgregor Kent Garrett Jade Eyles Rinaldo Bellomo
author_facet	Laurence Weinberg Michael Hua-Gen Li Leonid Churilov Christopher Macgregor Kent Garrett Jade Eyles Rinaldo Bellomo
author_sort	Laurence Weinberg
title	The effects of 0.9% saline versus Plasma-Lyte 148 on renal function as assessed by creatinine concentration in patients undergoing major surgery: A single-centre double-blinded cluster crossover trial.
title_short	The effects of 0.9% saline versus Plasma-Lyte 148 on renal function as assessed by creatinine concentration in patients undergoing major surgery: A single-centre double-blinded cluster crossover trial.
title_full	The effects of 0.9% saline versus Plasma-Lyte 148 on renal function as assessed by creatinine concentration in patients undergoing major surgery: A single-centre double-blinded cluster crossover trial.
title_fullStr	The effects of 0.9% saline versus Plasma-Lyte 148 on renal function as assessed by creatinine concentration in patients undergoing major surgery: A single-centre double-blinded cluster crossover trial.
title_full_unstemmed	The effects of 0.9% saline versus Plasma-Lyte 148 on renal function as assessed by creatinine concentration in patients undergoing major surgery: A single-centre double-blinded cluster crossover trial.
title_sort	effects of 0.9% saline versus plasma-lyte 148 on renal function as assessed by creatinine concentration in patients undergoing major surgery: a single-centre double-blinded cluster crossover trial.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/51cd684e9a81477095d104783328fc62
work_keys_str_mv	AT laurenceweinberg theeffectsof09salineversusplasmalyte148onrenalfunctionasassessedbycreatinineconcentrationinpatientsundergoingmajorsurgeryasinglecentredoubleblindedclustercrossovertrial AT michaelhuagenli theeffectsof09salineversusplasmalyte148onrenalfunctionasassessedbycreatinineconcentrationinpatientsundergoingmajorsurgeryasinglecentredoubleblindedclustercrossovertrial AT leonidchurilov theeffectsof09salineversusplasmalyte148onrenalfunctionasassessedbycreatinineconcentrationinpatientsundergoingmajorsurgeryasinglecentredoubleblindedclustercrossovertrial AT christophermacgregor theeffectsof09salineversusplasmalyte148onrenalfunctionasassessedbycreatinineconcentrationinpatientsundergoingmajorsurgeryasinglecentredoubleblindedclustercrossovertrial AT kentgarrett theeffectsof09salineversusplasmalyte148onrenalfunctionasassessedbycreatinineconcentrationinpatientsundergoingmajorsurgeryasinglecentredoubleblindedclustercrossovertrial AT jadeeyles theeffectsof09salineversusplasmalyte148onrenalfunctionasassessedbycreatinineconcentrationinpatientsundergoingmajorsurgeryasinglecentredoubleblindedclustercrossovertrial AT rinaldobellomo theeffectsof09salineversusplasmalyte148onrenalfunctionasassessedbycreatinineconcentrationinpatientsundergoingmajorsurgeryasinglecentredoubleblindedclustercrossovertrial AT laurenceweinberg effectsof09salineversusplasmalyte148onrenalfunctionasassessedbycreatinineconcentrationinpatientsundergoingmajorsurgeryasinglecentredoubleblindedclustercrossovertrial AT michaelhuagenli effectsof09salineversusplasmalyte148onrenalfunctionasassessedbycreatinineconcentrationinpatientsundergoingmajorsurgeryasinglecentredoubleblindedclustercrossovertrial AT leonidchurilov effectsof09salineversusplasmalyte148onrenalfunctionasassessedbycreatinineconcentrationinpatientsundergoingmajorsurgeryasinglecentredoubleblindedclustercrossovertrial AT christophermacgregor effectsof09salineversusplasmalyte148onrenalfunctionasassessedbycreatinineconcentrationinpatientsundergoingmajorsurgeryasinglecentredoubleblindedclustercrossovertrial AT kentgarrett effectsof09salineversusplasmalyte148onrenalfunctionasassessedbycreatinineconcentrationinpatientsundergoingmajorsurgeryasinglecentredoubleblindedclustercrossovertrial AT jadeeyles effectsof09salineversusplasmalyte148onrenalfunctionasassessedbycreatinineconcentrationinpatientsundergoingmajorsurgeryasinglecentredoubleblindedclustercrossovertrial AT rinaldobellomo effectsof09salineversusplasmalyte148onrenalfunctionasassessedbycreatinineconcentrationinpatientsundergoingmajorsurgeryasinglecentredoubleblindedclustercrossovertrial
_version_	1718413924415569920

The effects of 0.9% saline versus Plasma-Lyte 148 on renal function as assessed by creatinine concentration in patients undergoing major surgery: A single-centre double-blinded cluster crossover trial.

Ejemplares similares