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Background: Preoperative anaemia is associated with increased use of blood transfusions, a greater risk of postoperative complications, and patient morbidity. The IRON NOF trial aimed to investigate whether the administration of i.v. iron in anaemic patients during hip fracture surgery reduced the need for blood transfusion and improved patient outcomes. Methods: This phase III double-blind, randomised, placebo-controlled trial included patients >60 yr old with preoperative anaemia undergoing surgery for femoral neck or subtrochanteric fracture across seven Australian Hospitals. Patients were randomly allocated on a 1:1 basis to receive either i.v. iron carboxymaltose 1000 mg or placebo (saline) at operation. The primary endpoint was blood transfusion use, with secondary endpoints of haemoglobin concentration at 6 weeks, length of hospital stay, rehabilitation duration to discharge, and 6-month mortality. Subgroup analysis compared outcomes in patients <80 yr old and patients >80 yr old. All analyses were performed by intention-to-treat. This trial was terminated early because of jurisdictional changes of more restrictive transfusion practices and changes in consent requirements. Results: Participants (n=143) were recruited between February 2013 and May 2017. There was no difference observed in the incidence of blood transfusion between the treatment group (18/70) (26%) compared with the placebo group (27/73) (37%) (odds ratio for transfusion if receiving placebo: 1.70; 95% confidence interval [CI] 0.83-3.47; P=0.15) and there was no overall difference in the median number of blood units transfused between groups (odds ratio 1.52; 95% CI 0.77-3.00; P=0.22). Patients receiving i.v. iron had a higher haemoglobin 6 weeks after intervention compared with the placebo group (Hb 116 g L-1vs 108 g L-1; P=0.01). No difference was observed in length of hospital stay, rehabilitation duration to discharge, or 6-month mortality. However, in younger patients without major bleeding, the use of placebo compared with i.v. iron was associated with an increased number of units of blood transfused (placebo transfusion incidence rate ratio 3.88; 95% CI 1.16-13.0; P=0.03). Conclusions: In anaemic patients undergoing surgery for hip fracture, i.v. iron did not reduce the overall proportion of patients receiving blood transfusion. The use of i.v. iron may reduce the amount of blood transfused in younger patients. The use of i.v. iron is associated with increased haemoglobin concentrations 6 weeks after the operation. Clinical trial registration: ACTRN12612000448842.
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AIM: To describe contemporary routine practice regarding rapid pre-loading of intravenous fluid management prior to epidural analgesia during labour and birth. BACKGROUND: Midwives are the key health professionals providing care for women before, during and after an epidural in labour. Part of this management involves maternal hydration; however, how midwives assess and manage maternal hydration and fluid management is not well understood. Prior to the administration of a low dose epidural for pain relief a rapid intravenous pre-loading of between 500-1000 mls of crystalloid fluids is administered to the pregnant women. Currently, there is limited evidence available to assess if intravenous pre-loading reduces maternal hypotension and foetal bradycardia. Anecdotal evidence suggests that wide variation in clinical practice in relation to volume of fluid administered, fluid status assessment and clinical documentation occurs. DESIGN: A retrospective medical health record review, in a regional Australian maternity hospital. METHODS: A retrospective medical health record review chart review from women who received an epidural for pain relief during labour and birth (June-September 2015). RESULTS: Data from 293 charts were collected, including: maternal factors; blood pressure distributions; maternal fluid status; types, concentration and timing of analgesia loading doses; IV fluid loading volumes; maternal hypotension, foetal outcomes and documentation of fluid balance charts. Wide variation in clinical practice was evident with midwives administering pre-loading fluid volumes ranging from 250-1000 ml. Midwifery assessment, documentation and practice pertaining to hydration was inconsistent and lacking. CONCLUSION: Management of intravenous fluids during labour is fragmented. Although fluid balance charts are used internationally to assess maternal hydration, documentation of fluid balance status was poor. Multi-professional collaboration between obstetrics, anaesthetics and midwifery is required to address this wide variation and reach consensus on best practice based on what evidence is currently available.