Using lactate testing to improve maternal sepsis identification: a multi-country test accuracy study: LACTate in mATernal sEpsis
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Date
16-03-22
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Publisher
Kamuzu University of Health Sciences
Abstract
Type of study
This is a prospective, multi-site, phase III test accuracy study.
Problem
Maternal infections left untreated may lead to sepsis and consequently death. Maternal sepsis can develop in pregnant women and women who have recently experienced pregnancy and is defined as a life-threatening condition with organ dysfunction resulting from infection during pregnancy, childbirth, post-abortion, or the post-partum period”(1) . Multiple studies have tested the accuracy of blood lactate for the early identification of people likely to experience worsening sepsis in high income adult populations. The evidence suggests that lactate levels are informative, and a tiered recommendation was made of different actions based on the lactate measurement. A raised lactate level (>2 mmol/L) can be used as a triage tool to prompt initiation of urgent treatment and the patients can be identified as more severe (lactate level of >4 mmol/L) prompting more intensive treatment and monitoring. The need for high quality evidence of diagnostic accuracy for this test has been highlighted as a research priority. Currently there is no high-quality test accuracy study of lactate testing for maternal sepsis. After multiple systematic reviews we concluded there is no reliable evidence of test accuracy in the pregnant population. There is need to investigate if a lactate measurement has incremental benefit over conventional maternal vital sign assessment in the diagnosis of sepsis and identification of women at risk of severe morbidity or mortality in low resource settings. This study can help determine the diagnostic and prognostic accuracy of venous lactate measurement in the maternity populations, in low resource settings, which is unknown.
Broad objective
The broad objective of the Lactate test accuracy study is to determine the diagnostic accuracy of maternal venous lactate measurement in addition to maternal vital sign thresholds, in maternal sepsis in low-resource health facility settings in Malawi, Uganda and Pakistan.
Specific objectives
The specific objectives are to assess the immediate diagnostic value of lactate testing by comparing the baseline index test with baseline reference standard; to assess short-term predictive value of lactate testing, by comparing the baseline index test with 24-hour reference standard, in those without sepsis at baseline; to explore if baseline venous lactate, in addition to vital sign measurements, improves prediction of severe morbidity and mortality from infection; to explore if the test accuracy of lactate in addition to maternal vital sign monitoring alone varies by the prespecified subgroups of pregnancy status (pregnant or post-delivery / post miscarriage / postabortion) and recruitment country; to explore and examine the effects of adjusting the threshold values for both vital sign and lactate assessment on the sensitivity and specificity of the index tests; and finally to explore and validate the use of an alternative reference standard in which the SOFA score is modified to use maternity specific ranges for creatinine and platelet concentration
Methods
The study will be conducted in the maternity wards at Queen Elizabeth Central Hospital in Blantyre, Malawi. Women will be recruited to have an additional blood sample taken at two time points during admission; at day 0 and day one for lactate testing. There will be no additional clinical procedures or interventions conducted with eligible women by members of the study team or by hospital staff for other reasons than those of their usual clinical practice. We will estimate diagnostic accuracy to detect sepsis as defined by comparison with the reference standard diagnosis of sepsis, at baseline and at 24 hours. We will compare (a) baseline index test with baseline reference standard to determine immediate diagnostic value, (b) baseline index test with 24-hour reference standard in those without sepsis at baseline to determine short-term predictive value and (c) baseline index test with occurrence of infection related “severe maternal outcome” (near miss or maternal mortality) prior to hospital discharge to determine predictive value for severe morbidity or mortality
Expected findings
If lactate testing in this population is found to offer incremental benefit over the standard sepsis triggering approach, and is feasible to implement in an integrated approach, then this has the potential to improve maternal sepsis outcomes.
Dissemination
The study report will be submitted to College of Medicine Research and Ethics committee (COMREC). Research findings will be disseminated via download on relevant websites and will also be shared with both local (QECH, Blantyre DHO, community gatekeepers and participants) and global stakeholders through research dissemination conferences, peer reviewed publications and via participant and public information groups, national and international forums and conferences and.
Data will be retained and be supported to produce additional secondary outputs as appropriate.
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Keywords
Using lactate testing to improve maternal sepsis identification: