Clout Madeleine, Harris Tracy, Rogers Chris, Culliford Lucy, Taylor Jodi, Angelini Gianni, Narayan Pradeep, Reeves Barnaby, Hillier James, Ashton Kate, Sarkar Kunal, Ascione Raimondo
Bristol Cardiovascular, Faculty of Health Science, University of Bristol, Bristol, United Kingdom.
Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata, India.
JMIR Res Protoc. 2017 Jun 19;6(6):e119. doi: 10.2196/resprot.7386.
Diabetes mellitus is a major risk factor for prolonged hospital stays, renal failure, and mortality in patients having coronary artery bypass grafting (CABG). Complications pose a serious threat to patients and prolong intensive care and hospital stays. Low glomerular filtration rate (GFR) due to existing renal impairment or volume depletion may exacerbate acute renal impairment/failure in these patients. Preoperative volume replacement therapy (VRT) is reported to increase the GFR and we hypothesize that VRT will reduce renal impairment and related complications in diabetic patients.
The objective of this study is to establish the efficacy of preoperative VRT in reducing postoperative complications in diabetic patients undergoing CABG surgery. Time to "fit for discharge", incidence of postoperative renal failure, cardiac injury, inflammation, and other health outcomes will be investigated.
In this open parallel group randomized controlled trial, 170 diabetic patients undergoing elective or urgent CABG surgery received 1 mL/kg/hour of Hartmann's solution for 12 consecutive hours prior to surgery, versus routine care. The primary outcome was time until participants were "fit for discharge", which is defined as presence of: normal temperature, pulse, and respiration; normal oxygen saturation on air; normal bowel function; and physical mobility. Secondary outcomes included: incidence of renal failure; markers of renal function, inflammation, and cardiac damage; operative morbidity; intensive care stay; patient-assessed outcome, including the Coronary Revascularization Outcome Questionnaire; and use of hospital resources.
Recruitment started in July 2010. Enrolment for the study was completed in July 2014. Data analysis commenced in December 2016. Study results will be submitted for publication in the summer of 2017.
VRT is a relatively easy treatment to administer in patients undergoing surgical procedures who are at risk of renal failure. This experimental protocol will increase scientific and clinical knowledge of VRT in diabetic patients undergoing elective or urgent CABG surgery. Findings supporting the efficacy of this intervention could easily be implemented in the health care system.
International Standard Randomized Controlled Trial Number (ISRCTN): 02159606; http://www.controlled-trials.com/ISRCTN02159606 (Archived by WebCite at http://www.webcitation.org/6rDkSSkkK).
糖尿病是冠状动脉旁路移植术（CABG）患者住院时间延长、肾衰竭及死亡的主要危险因素。并发症对患者构成严重威胁，并延长重症监护和住院时间。因既有肾功能损害或容量耗竭导致的低肾小球滤过率（GFR）可能会加重这些患者的急性肾功能损害/衰竭。据报道，术前容量替代疗法（VRT）可提高GFR，我们推测VRT将减少糖尿病患者的肾功能损害及相关并发症。
本研究的目的是确定术前VRT对降低接受CABG手术的糖尿病患者术后并发症的疗效。将调查达到“适合出院”的时间、术后肾衰竭、心脏损伤、炎症及其他健康结局的发生率。
在这项开放平行组随机对照试验中，170例接受择期或急诊CABG手术的糖尿病患者在术前连续12小时接受1 mL/kg/小时的哈特曼氏溶液，对照组接受常规护理。主要结局是参与者达到“适合出院”的时间，其定义为具备以下条件：体温、脉搏和呼吸正常；空气中氧饱和度正常；肠功能正常；身体活动能力正常。次要结局包括：肾衰竭发生率；肾功能、炎症和心脏损伤标志物；手术发病率；重症监护住院时间；患者评估结局，包括冠状动脉血运重建结局问卷；以及医院资源的使用情况。
招募工作于2010年7月开始。该研究的入组工作于2014年7月完成。数据分析于2016年12月开始。研究结果将于2017年夏季提交发表。
VRT对于有肾衰竭风险的手术患者来说是一种相对易于实施的治疗方法。本试验方案将增加对接受择期或急诊CABG手术的糖尿病患者VRT的科学及临床认识。支持该干预措施疗效的研究结果可轻松应用于医疗保健系统。
国际标准随机对照试验编号（ISRCTN）：02159606；http://www.controlled-trials.com/ISRCTN02159606（由WebCite存档于http://www.webcitation.org/6rDkSSkkK）
