CTRI/2024/10/075534尚未招募4 期
Early Vasopressor Administration And Postoperative Organ Dysfunction In Elective Abdominal Surgery: A Randomized Controlled Study
AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年10月28日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To assess the difference in severity of organ dysfunction in the first seven postoperative days between the two groups using the mean SOFA score
研究概览
简要总结
| Intraoperative hypotension is common side effect of general anaesthesia. It has a multifactorial aetiology and associates with increased mortality, stroke, cardiac morbidity, acute kidney injury, and delirium. Even mild hypotension is potentially deleterious. As the blood pressure threshold decreases, the risk of injury increases, and appears to occur with a much shorter duration.Maintenance of adequate BP and organ perfusion is, therefore, a key priority in the perioperative period. Current strategies include intravenous (IV) fluids and vasopressors. Norepinephrine, a mixed α1 and β1-adrenergic agonist, offers a favourable pharmacological profile to maintain BP in the perioperative setting. Thus, administration of norepinephrine may provide an effective strategy to safely achieve and maintain BP thresholds and prevent or attenuate hypotension in the intra- and postoperative period.The sequential organ failure assessment (SOFA) score is a simple and objective scoring system that represents degree and progression of dysfunction with a four-point assessment for each of the six organ systems (central nervous system, cardiovascular system, respiratory system, renal system, liver and coagulation). This assessment was initially developed to describe and quantify organ function and has been validated in various clinical situations. An increase in the SOFA score during ICU treatment has also been associated with progressive organ failure and increased mortality in various clinical settings . Perioperative administration of vasoactive drugs may reduce postoperative complications and hospital length of stay in adult patients having major abdominal surgery and length of hospital stay.In this study, We aim to determine the association between the mean SOFA score for 7 days and postoperative outcomes in patients who have early administration of noradrenaline for intraoperative hypotension during major abdominal surgery. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 to 70 years undergoing elective major open abdominal surgery with general anaesthesia with expected surgical duration of more than 120 minutes.
排除标准
- •Patients who decline to give consent.
- •Patients with poorly controlled hypertension 3)K/c/o CAD, CKD, CLD 4)Patients with primary end organ dysfunction.
- •Patients on monoamine oxidase inhibitors 6)Patients who were pregnant or breastfeeding.
- •Patients with phaechromocytoma/paraganglionoma.
结局指标
主要结局
To assess the difference in severity of organ dysfunction in the first seven postoperative days between the two groups using the mean SOFA score
时间窗: 7 days
次要结局
- Difference in 28-day mortality between the groups(28 days)
- Difference in the individual components of the primary outcome(7 days)
- Difference in total fluid infused(24 hours)
- Difference in intraoperative blood loss(Duration of surgery)
- Difference in cumulative fluid balance at Day7(7 days)
- Difference in lactate levels lactate level at end of surgery, 24 post-op(at the end of surgery , 24 hours)
- P/F ratio at end of surgery and at 24h post op(at the end of surgery , 24 hours)
- Difference in unplanned ICU stay between the groups.(28 days)
- Difference in length of hospital stay between the groups(Day 28)
- Difference in duration of mechanical ventilation(28 days)
- Difference in incidence of AKI(28 days)
- Difference in organ failure free days (no need for vasopressors, NIV/IMV or RRT)(28 days)
- Difference in mean I-FEED score at day 7 and time to GI-2 recovery(7 days)
研究者
Rahul Kumar Anand
AIIMS,New Delhi
研究点 (1)
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