Using automated pump-delivery devices to reduce the incidence of excessive fluid administration during pediatric dental surgery: a randomized-controlled trial.

PURPOSE: The harms caused by excessive perioperative intravenous (IV) fluid administration are both well recognized and avoidable. The purpose of this study was to compare the incidence of excess intraoperative fluid administration in pediatric dental surgery patients when either an automated pump-delivery device or a manual gravity-drip device is used. METHODS: We randomly assigned American Society of Anesthesiologists physical status I and II pediatric dental surgery patients to receive IV fluid via either a manual gravity-drip or automated pump-delivery device. Prior to each case, the attending anesthesiologist determined the target volume of maintenance IV fluid to be administered based on patient weight, estimated fluid deficits, and expected case length. The intraoperative IV fluid delivered was determined at the end of the case by the change in the IV bag weight. The primary outcome was the proportion of procedures that delivered ≥ 10% of the target IV fluid volume. RESULTS: We recruited 105 children aged two to 12 yr (n = 49 in the automated pump-delivery device; n = 53 in the manual gravity-drip device). The proportion of excessive fluid administration was 8/49 (16%) in the automated pump-delivery device group compared with 33/53 (62%) in the gravity-drip group (relative risk of excessive fluid administration, 0.26; 95% confidence interval, 0.13 to 0.51; P < 0.001). CONCLUSION: Intraoperative fluid administration using an automated pump-delivery device decreased the incidence of excessive IV fluid administration in pediatric dental surgery patients. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT03312452); registered 17 October 2017.

RéSUMé: OBJECTIF: Les effets néfastes causés par une administration liquidienne intraveineuse (IV) périopératoire excessive sont à la fois bien connus et évitables. L'objectif de cette étude était de comparer l'incidence d'administration liquidienne peropératoire excessive chez les patients pédiatriques de chirurgie dentaire lors de l'utilisation d'une pompe à perfusion automatique vs un système goutte à goutte manuel par gravité. MéTHODE: Nous avons randomisé des patients pédiatriques de chirurgie dentaire de statut physique I et II selon l'American Society of Anesthesiologists à recevoir des liquides intraveineux soit par un système goutte à goutte manuel par gravité ou via une pompe à perfusion automatique. Avant chaque cas, l'anesthésiologiste en charge a déterminé le volume cible de liquide IV de maintien à administrer selon le poids du patient, les déficits liquidiens estimés, et la durée anticipée du cas. La quantité de liquides IV peropératoires administrés était déterminée à la fin du cas par le changement du poids du sac de liquide IV. Le critère d'évaluation principal était la proportion d'interventions ayant administré ≥ 10 % du volume liquidien IV cible. RéSULTATS: Nous avons recruté 105 enfants âgés de deux à 12 ans (n = 49 dans le groupe pompe automatique; n = 53 dans le groupe goutte à goutte manuel). La proportion d'administration liquidienne excessive était de 8/49 (16 %) dans le groupe pompe automatique, comparativement à 33/53 (62 %) dans le groupe goutte à goutte (risque relatif d'administration liquidienne excessive, 0,26; intervalle de confiance 95 %, 0,13 à 0,51; P < 0,001). CONCLUSION: L'administration liquidienne peropératoire à l'aide d'une pompe a réduit l'incidence d'administration liquidienne IV excessive chez des patients pédiatriques de chirurgie dentaire. ENREGISTREMENT DE L'éTUDE: ww.clinicaltrials.gov (NCT03312452); enregistrée le 17 octobre 2017.

IgG1 as a potential biomarker of post-chemotherapeutic relapse in visceral leishmaniasis, and adaptation to a rapid diagnostic test.

BACKGROUND: Visceral leishmaniasis (VL), caused by protozoa of the Leishmania donovani complex, is a widespread parasitic disease of great public health importance; without effective chemotherapy symptomatic VL is usually fatal. Distinction of asymptomatic carriage from progressive disease and the prediction of relapse following treatment are hampered by the lack of prognostic biomarkers for use at point of care. METHODOLOGY/PRINCIPAL FINDINGS: All IgG subclass and IgG isotype antibody levels were determined using unpaired serum samples from Indian and Sudanese patients with differing clinical status of VL, which included pre-treatment active VL, post-treatment cured, post-treatment relapsed, and post kala-azar dermal leishmaniasis (PKDL), as well as seropositive (DAT and/or rK39) endemic healthy controls (EHCs) and seronegative EHCs. L. donovani antigen-specific IgG1 levels were significantly elevated in relapsed versus cured VL patients (p<0.0001). Using paired Indian VL sera, consistent with the known IgG1 half-life, IgG1 levels had not decreased significantly at day 30 after the start of treatment (p = 0.8304), but were dramatically decreased by 6 months compared to day 0 (p = 0.0032) or day 15 (p<0.0001) after start of treatment. Similarly, Sudanese sera taken soon after treatment did not show a significant change in the IgG1 levels (p = 0.3939). Two prototype lateral flow immunochromatographic rapid diagnostic tests (RDTs) were developed to detect IgG1 levels following VL treatment: more than 80% of the relapsed VL patients were IgG1 positive; at least 80% of the cured VL patients were IgG1 negative (p<0.0001). CONCLUSIONS/SIGNIFICANCE: Six months after treatment of active VL, elevated levels of specific IgG1 were associated with treatment failure and relapse, whereas no IgG1 or low levels were detected in cured VL patients. A lateral flow RDT was successfully developed to detect anti-Leishmania IgG1 as a potential biomarker of post-chemotherapeutic relapse.

Significantly lower anti-Leishmania IgG responses in Sudanese versus Indian visceral leishmaniasis.

BACKGROUND: Visceral leishmaniasis (VL), a widely distributed systemic disease caused by infection with the Leishmania donovani complex (L. donovani and L. infantum), is almost always fatal if symptomatic and untreated. A rapid point-of-care diagnostic test for anti-Leishmania antibodies, the rK39-immunochromatographic test (rK39-ICT), has high sensitivity and specificity in South Asia but is less sensitive in East Africa. One of the underlying reasons may be continent-specific molecular diversity in the rK39 antigen within the L. donovani complex. However, a second reason may be differences in specific IgG anti-Leishmania levels in patients from different geographical regions, either due to variable antigenicity or immunological response. METHODOLOGY/PRINCIPAL FINDINGS: We determined IgG titres of Indian and Sudanese VL patients against whole cell lysates of Indian and Sudanese L. donovani strains. Indian VL patients had significantly higher IgG titres against both L. donovani strains compared to Sudanese VL patients (p<0.0001). Mean reciprocal log10 50% end-point titres (1/log10t50) were i) 3.80 and 3.88 for Indian plasma and ii) 2.13 and 2.09 for Sudanese plasma against Indian and Sudanese antigen respectively (p<0.0001). Overall, the Indian VL patients therefore showed a 46.8-61.7 -fold higher mean ELISA titre than the Sudanese VL patients. The higher IgG titres occurred in children (<16 years old) and adults of either sex from India (mean 1/log10t50: 3.60-4.15) versus Sudan (mean 1/log10t50: 1.88-2.54). The greatest difference in IgG responses was between male Indian and Sudanese VL patients of ≥ 16 years old (mean 1/log10t50: 4.15 versus 1.99 = 144-fold (p<0.0001). CONCLUSIONS/SIGNIFICANCE: Anti-Leishmania IgG responses among VL patients in Sudan were significantly lower than in India; this may be due to chronic malnutrition with Zn(2+) deficiency, or variable antigenicity and capacity to generate IgG responses to Leishmania antigens. Such differential anti-Leishmania IgG levels may contribute to lower sensitivity of the rK39-ICT in East Africa.