The role of icodextrin in peritoneal dialysis: protocol for a systematic review and meta-analysis

Monika Becker, Institute for Research in Operative Medicine (IFOM), Department for Evidence Based Health Service Research, Faculty of Health, Department of Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, Building 38, 51109, Cologne, Germany. monika.becker@uni-wh.de.
Stefanie Bühn, Institute for Research in Operative Medicine (IFOM), Department for Evidence Based Health Service Research, Faculty of Health, Department of Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, Building 38, 51109, Cologne, Germany.
Jessica Breuing, Institute for Research in Operative Medicine (IFOM), Department for Evidence Based Health Service Research, Faculty of Health, Department of Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, Building 38, 51109, Cologne, Germany.
Catherine A. Firanek, Medical Affairs, Baxter Healthcare International, 1 Baxter Pkwy, Deerfield, IL, 60015, USA.
Simone Hess, Institute for Research in Operative Medicine (IFOM), Department for Evidence Based Health Service Research, Faculty of Health, Department of Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, Building 38, 51109, Cologne, Germany.
Hisanori Nariai, Baxter Co. Ltd., Toranomon Hills Mori Tower 20F, 23-1, Toranomon 1-Chome, Minato-ku, Tokyo, 105-6320, Japan.
Mark R. Marshall, Medical Affairs, Baxter Healthcare (Asia) Pte Ltd., 150 Beach Road, #30-01/08 Gateway West, Singapore, 189720, Singapore.
James A. Sloand, Medical Affairs, Baxter Healthcare International, 1 Baxter Pkwy, Deerfield, IL, 60015, USA.
Qiang Yao, Medical Affairs, Baxter (China) Investment Co., Ltd., 12F Century Business Plaza, 989 Changle Road, Shanghai, 200031, China.
Käthe Goossen, Institute for Research in Operative Medicine (IFOM), Department for Evidence Based Health Service Research, Faculty of Health, Department of Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, Building 38, 51109, Cologne, Germany.
Dawid Pieper, Institute for Research in Operative Medicine (IFOM), Department for Evidence Based Health Service Research, Faculty of Health, Department of Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, Building 38, 51109, Cologne, Germany.

Document Type

Journal Article

Publication Date

1-30-2019

Journal

Systematic reviews

Volume

8

Issue

1

DOI

10.1186/s13643-019-0959-y

Keywords

Glucose-based solutions; Icodextrin; Meta-analysis; Peritoneal dialysis; Systematic review

Abstract

BACKGROUND: Previous meta-analyses have found several advantages of icodextrin compared with glucose in the application of peritoneal dialysis (PD), such as an improvement of peritoneal ultrafiltration during the long dwell and a reduction in episodes of uncontrolled fluid overload. However, the effect of icodextrin on patient-relevant outcomes remains unclear. This review aims to evaluate the benefits and harms of icodextrin in comparison with conventional glucose PD solution in patients with end-stage kidney disease receiving PD. METHODS: Randomized controlled trials of icodextrin comparing with conventional glucose solution in patients with end-stage kidney disease who received PD will be deemed eligible. We will conduct systematic searches in MEDLINE, EMBASE, CENTRAL, Ichushi-Web, Chinese and Japanese databases, and in clinical trials registries (ClinicalTrials.gov, International Clinical Trials Registry Platform Search Portal (ICTRP), EU Clinical Trials Register, Japan Registries Network (JPRN), China's Clinical Trial Registry (ChiCTR)). Furthermore, we will check conference proceedings and search references from relevant studies manually. Relevant pharmaceutical companies, authors, and experts will be contacted in an effort to identify further studies. We will not apply any limitations regarding language, publication status, and publication date when searching for eligible studies. The selection of studies, data extraction, and risk of bias assessment will be carried out by two independent reviewers. Data synthesis will be performed using RevMan 5 software with either a fixed effects model or random-effects model, depending on the presence of heterogeneity. For the assessment of statistical heterogeneity, I will be calculated. Sources of clinical heterogeneity will be evaluated through subgroup analyses. If there are ten or more studies included in the meta-analysis, we will investigate the publication bias using funnel plots and Egger's test. The quality of the body of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. DISCUSSION: We assume that our systematic review will be more comprehensive compared to those published previously due to contacting the relevant pharmaceutical companies and a systematic search of published and unpublished non-English studies from China, Taiwan, and Japan. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018096951.

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