Evidence review for fluid restriction in bacterial meningitis
Evidence review G1
NICE Guideline, No. 240
Fluid restriction in bacterial meningitis
Review question
What is the effectiveness of fluid restriction in bacterial meningitis?
Introduction
Bacterial meningitis is a rare but serious infection, which can occur in any age group. Careful management of fluid and electrolyte balance is important in the treatment of meningitis. Fluid restriction in the initial management of bacterial meningitis has been advocated.
The aim of this review is to establish the effectiveness of fluid restriction in the early management of bacterial meningitis.
Summary of the protocol
See Table 1 for a summary of the Population, Intervention, Comparison and Outcome (PICO) characteristics of this review.
Table 1
Summary of the protocol (PICO table).
For further details see the review protocol in appendix A.
Methods and process
This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual. Methods specific to this review question are described in the review protocol in appendix A and the methods document (supplementary document 1).
Declarations of interest were recorded according to NICE’s conflicts of interest policy.
Effectiveness evidence
Included studies
Two randomised controlled trials were included in this review (Duke 2002, Singhi 1995).
The included studies are summarised in Table 2.
Both studies (Duke 2002, Singhi 1995) compared restricted fluids to maintenance fluids in babies and children.
See the literature search strategy in appendix B and study selection flow chart in appendix C.
Excluded studies
Studies not included in this review are listed, and reasons for their exclusion are provided in appendix J.
Summary of included studies
Summaries of the studies that were included in this review are presented in Table 2.
Table 2
Summary of included studies.
See the full evidence tables in appendix D and the forest plots in appendix E.
Summary of the evidence
This section is a narrative summary of the findings of the review, as presented in the GRADE tables in appendix F. For details of the committee’s confidence in the evidence and how this affected recommendations, see The committee’s discussion and interpretation of the evidence.
The evidence was assessed as being low to very low quality due to risk of bias (arising from subjective outcome measurement), imprecision (due to low event rates), and the inclusion of indirect outcomes. All studies were conducted in lower middle-income countries, and 27% of participants were malnourished in 1 study (Duke 2002). See the GRADE tables in appendix F for the certainty of the evidence for each individual outcome.
The evidence showed no important difference between restricted fluids and maintenance fluids for all-cause mortality, acute hyponatraemia, acute pulmonary oedema, or hydrocephalus in babies and children. There was some evidence for a higher rate of neurological impairment and epilepsy associated with fluid restriction, and a higher rate of acute facial oedema associated with maintenance fluids, although all these effect estimates were seriously or very seriously imprecise.
No other outcomes in the protocol were reported by any studies.
See appendix F for full GRADE tables.
Economic evidence
Included studies
A single economic search was undertaken for all topics included in the scope of this guideline, but no economic studies were identified which were applicable to this review question.
Economic model
No economic modelling was undertaken for this review because the committee agreed that other topics were higher priorities for economic evaluation. This was because the committee did not expect their recommendations would change current NHS practice. Furthermore, there is other NICE guidance on fluid therapy in adults, young people, and children.
The committee’s discussion and interpretation of the evidence
The outcomes that matter most
Bacterial meningitis is associated with high rates of mortality and morbidity. Fluid management may reduce mortality and morbidity in bacterial meningitis, and all-cause mortality and any long-term neurological impairment were prioritised as critical outcomes because of the severity of these outcomes. Functional impairment was also prioritised as a critical outcome in adults because of the potential long-term impact on the ability to carry out certain activities of daily life. Severe developmental delay was prioritised as a critical outcome in neonates, babies, and children as it is a more relevant and important outcome for this population.
Functional impairment (in neonates, babies, and children), epilepsy or seizures, hearing impairment and serious intervention-related adverse effects were chosen as important outcomes because these outcomes are relatively common after bacterial meningitis and may be related to fluid management. In adults, length of hospitalisation was also chosen as an important outcome because this may be considered as an indicator of treatment effectiveness and was expected to be commonly reported in trials.
The quality of the evidence
The quality of the evidence was assessed using GRADE methodology. The evidence was rated as very low to low quality due to risk of bias (arising from subjective outcome measurement), imprecision (due to low event rates), and the inclusion of indirect populations and outcomes.
No evidence was found that reported functional impairment, severe developmental delay, hearing impairment, or length of hospitalisation.
Benefits and harms
The committee considered the evidence comparing fluid restriction and maintenance fluid in the treatment of bacterial meningitis in babies and children, that showed no important difference for mortality, and a higher rate of neurological impairment and epilepsy associated with fluid restriction. The committee acknowledged the low quality and limited evidence but were concerned that fluid restriction showed harm for a critical outcome. Based on this best available evidence, and their clinical knowledge and experience, the committee agreed to recommend that fluid intake is not routinely restricted to below routine maintenance needs in people with bacterial meningitis. The committee discussed that there are some situations in which fluid restriction should be considered. For example, if a patient had a lot of fluid resuscitation during an acute unstable phase, then fluid overload could occur in recovery phase, in which case it would be clinically appropriate to restrict fluid intake. However, the committee agreed that fluid restriction should only be considered in certain cases and based on the individual clinical presentation and needs of the patient.
This review did not provide evidence on routes of fluid administration, however the committee felt that for patient safety, it was important to provide a recommendation on route of administration for maintenance fluids based on good clinical practice and their expert opinion. The committee agreed that people with bacterial meningitis do not need to have all their fluids as intravenous fluids and were aware of the risk of complications related to the intravenous route. Therefore, the committee agreed that maintenance fluid should be given orally or by enteral tube if tolerated to avoid unnecessary intravenous fluids.
Cost effectiveness and resource use
This review question was not prioritised for economic analysis and therefore the committee made a qualitative assessment of the likely cost-effectiveness of their recommendations. The committee considered that their recommendations with respect to fluid restriction were all very low cost and were therefore likely to be cost-effective as they were underpinned by the best available clinical evidence allied with their expertise and knowledge to maximise health related quality of life. The committee noted that their recommendations were in line with current NHS practice and that they would not have a significant resource impact.
Recommendations supported by this evidence review
This evidence review supports recommendations 1.9.1 and 1.9.2.
References – included studies
Duke 2002
Duke, T., Mokela, D., Frank, D., Michael, A., Paulo, T., Mgone, J., Kurubi, J., Management of meningitis in children with oral fluid restriction or intravenous fluid at maintenance volumes: a randomised trial, Annals of Tropical Paediatrics, 22, 145–57, 2002 [PubMed: 12070950]Singhi 1995
Singhi, S. C., Singhi, P. D., Srinivas, B., Narakesri, H. P., Ganguli, N. K., Sialy, R., Walia, B. N., Fluid restriction does not improve the outcome of acute meningitis, Pediatric Infectious Disease Journal, 14, 495–503, 1995 [PubMed: 7667054]
Effectiveness
Economic
No studies were identified which were applicable to this review question.
Appendices
Appendix A. Review protocols
Review protocol for review question: What is the effectiveness of fluid restriction in bacterial meningitis? (PDF, 249K)
Appendix B. Literature search strategies
Appendix C. Effectiveness evidence study selection
Study selection for review question: What is the effectiveness of fluid restriction in bacterial meningitis? (PDF, 103K)
Appendix D. Evidence tables
Evidence tables for review question: What is the effectiveness of fluid restriction in bacterial meningitis? (PDF, 184K)
Appendix E. Forest plots
Forest plots for review question: What is the effectiveness of fluid restriction in bacterial meningitis? (PDF, 137K)
Appendix F. GRADE tables
GRADE tables for review question: What is the effectiveness of fluid restriction in bacterial meningitis? (PDF, 157K)
Appendix G. Economic evidence study selection
Study selection for: What is the effectiveness of fluid restriction in bacterial meningitis? (PDF, 105K)
Appendix H. Economic evidence tables
Economic evidence tables for review question: What is the effectiveness of fluid restriction in bacterial meningitis?
No evidence was identified which was applicable to this review question.
Appendix I. Economic model
Economic model for review question: What is the effectiveness of fluid restriction in bacterial meningitis?
No economic analysis was conducted for this review question.
Appendix J. Excluded studies
Excluded studies for review question: What is the effectiveness of fluid restriction in bacterial meningitis?
Excluded effectiveness studies
Table 6
Excluded studies and reasons for their exclusion.
Excluded economic studies
No studies were identified which were applicable to this review question.
Appendix K. Research recommendations – full details
Research recommendations for review question: What is the effectiveness of fluid restriction in bacterial meningitis?
No research recommendation was made for this review.
Final
Evidence review underpinning recommendations 1.9.1 and 1.9.2 in the NICE guideline
This evidence review was developed by NICE
Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
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