Safety, Feasibility, and Efficiency of a New Cooling Device Using Intravenous Cold Infusions for Fever Control
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Fever control plays a key role in therapy of patients with acute brain injury. The infusion of cold saline could serve as an alternative or additional method for targeted temperature management. However, it is difficult to estimate the amount of fluid required to achieve normothermia merely on the basis of body weight. There is no standardized load management regarding the administration of cold saline, and no closed-loop systems based on continuous temperature-controlled feedback are available. The primary purpose of the present study was to evaluate the feasibility, efficacy, and safety of a new automated fluid infusion system.
Twelve patients with acute brain injury and febrile episodes were treated with the automated infusion device tempedy (seiratherm GmbH, Herzogenaurach, Germany). Patients were included if bladder temperature still was ≥ 37.9 °C after administration of antipyretic medication, cold washing solutions, and ice packs more than 2 h earlier. The efficacy was examined by measuring the time and amount of fluid needed to reach and maintain target temperature. Feasibility and safety were assessed based on recording any technical difficulties with the new device and the occurrence of clinical signs of fluid overload such as acute pulmonary edema, electrolyte disturbances, or acid–base dysfunction.
The mean time was 73 min (range from 15 to 330 min) and 1650 ml the mean amount of fluid (21.2 ml/kg; SD 28.5 ml/kg) to reach the target temperature. The mean total fluid balance to reach and maintain the target temperature in the first 12 h was 1350 ml (SD 1550 ml). In the first 12 h 89.4% of the time temperature values were in the target range (median 95.3%, range 83.8–10%). No clinical signs of fluid overload such as an acute pulmonary edema or device-related adverse events occurred.
Target temperature management with the new automated infusion device is feasible. Although we provided first data regarding safety, further controlled randomized studies are needed to evaluate the long-time safety, as well as the best indications and timing for this cooling device.
KeywordsBrain injury Fever Cold saline Cold infusion Targeted temperature management
Device and disposables were provided free of charge by the company. Beyond this, no financial compensation was granted.
JFW contributed to study conception and design, acquisition of data, analysis and interpretation of data and drafting of manuscript. OB contributed to acquisition of data. EK contributed to analysis and interpretation of data and critical revision.
Source of Support
Compliance with Ethical Standards
Conflict of interest
The authors declare that they have no conflict of interest.
The study was approved by the ethics committee of Zurich, Switzerland.
- 11.Rochwerg B, Alhazzani W, Sindi A, Heels-Ansdell D, Thabane L, Fox-Robichaud A, Mbuagbaw L, Szczeklik W, Alshamsi F, Altayyar S, Ip WC, Li G, Wang M, Wludarcyk A, Zhou Q, Guyatt GH, Cook DJ, Jaeschke R, Annane D, Fluids in Sepsis and Septic Shock Group. Fluid resuscitation in sepsis: a systematic review and network meta-analysis. Ann Intern Med. 2014;161(5):347–55.CrossRefPubMedGoogle Scholar
- 12.Broessner G, Beer R, Lackner P, Helbok R, Fischer M, Pfausler B, Rhorer J, Kuppers-Tiedt L, Schneider D, Schmutzhard E. Prophylactic, endovasculary based, long-term normothermia in ICU patients with severe cerebrovascular disease: bicenter prospective, randomized trial. Stroke. 2009;40(12):e657–65.CrossRefPubMedGoogle Scholar
- 13.Broessner G, Lackner P, Fischer M, Beer R, Helbok R, Pfausler B, Schneider D, Schmutzhard E. Influence of prophylactic, endovasculary based normothermia on inflammation in ICU patients with severe cerebrovascular disease: a prospective, randomized trial. Stroke. 2010;41(12):2969–72.CrossRefPubMedGoogle Scholar
- 14.Den Hertog HM, van der Worp HB, van Gemert HM, Algra A, Kappelle LJ, van Gijn J, Koudstaal PJ, Dippel DW, PAIS Investigators. The Paracetamol (Acetaminophen) in Stroke (PAIS) trial: a multicentre, randomised, placebo-controlled, phase III trial. Lancet Neurol. 2009;8(5):434–40.CrossRefGoogle Scholar
- 15.Schiefecker AJ, Pfausler B, Beer R, Sohm F, Sabo J, Knauseder V, Fischer M, Dietmann A, Hackkl WO, Thome C, Schmutzhard E, Helbok R. Parenteral diclofenac infusion significantly decreases brain-tissue oxygen tension in patients with poor-grade aneurysmal subarachnoid haemorrhage. Crit Care. 2013;17(3):R88.CrossRefPubMedPubMedCentralGoogle Scholar
- 16.Deye N, Cariou A, Girardie P, Pichon N, Megarbane B, Midez P, Tonnelier JM, Boulain T, Outin H, Delahaye A, Cravoisy A, Mercat A, Blanc P, Santre C, Quintard H, Brivet F, Charpentier J, Garrigue D, Salengro R, Francois B, Quenot JP, Vincent F, Gueugniaud PY, Mira JP, Carli P, Vicaut E, Baud FJ. Endovascular versus external targeted temperature management for patients with out-of-hospital cardiac arrest: a randomized, controlled study. Circulation. 2015;132:182–93.CrossRefPubMedGoogle Scholar