Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes
关键词
抽象
描述
This is a randomized controlled trial being conducted at the Universiti Kebangsaan Malaysia Medical Center (UKMMC) with two arms; the control and treatment arms. The treatment arm will receive intravenous human albumin intraoperatively whilst the control arm will receive standard intraoperative fluid regimes. Primary endpoint will be overall complication rates whilst secondary endpoints are length of hospitalization, length of ICU care, duration of gastroparesis, pancreatic fistula rates, surgical site infection rates, duration of surgery and intraoperative bleeding.
Beyond the intraoperative fluid regimes, postoperative care follows the standardised UKMMC Enhanced Recovery After Surgery (ERAS) protocols which saw an improvement in overall outcomes in patients who underwent pancreaticoduodenectomies (PD). Preoperative care will include nutrition optimisation, counselling, antimicrobial prophylaxis, perioperative glycemic control and near-zero fluid balance.
Data collection will include:
i. preoperative data: age, sex, ethnicity, BMI on admission, date of admission, comorbidities and the New York Heart Association (NYHA) functional status classification. Further information will include biochemical markers such as serum albumin albumin, white cell count (WCC), renal functions.
ii. Intraoperative information: duration of surgery, estimated blood loss, pancreatic duct size, pancreatic texture, amount and type of fluid administered, fluid balances and type of anastomoses.
iii. postoperative data: fluid balances and renal function of postoperative day 1 to 3, duration of ICU stay, readmission to ICU, length of hospital stay, duration to standard feeds, grading of pancreatic fistula (where relevant), surgical site infection, duration to removal of urinary catheter, cardiac complications, renal and pulmonary complications, deep vein thrombosis, re-operation, and mortality.
日期
| 最后验证: | 12/31/2019 |
| 首次提交: | 03/24/2020 |
| 提交的预估入学人数: | 06/01/2020 |
| 首次发布: | 06/04/2020 |
| 上次提交的更新: | 07/04/2020 |
| 最近更新发布: | 07/07/2020 |
| 实际学习开始日期: | 01/26/2020 |
| 预计主要完成日期: | 11/25/2021 |
| 预计完成日期: | 11/25/2021 |
状况或疾病
干预/治疗
Drug: Treatment Arm
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| No Intervention: Control Arm Standard intraoperative fluid regime | |
| Experimental: Treatment Arm Intravenous human albumin 1g/kg at skin incision running at 100ml/hour | Drug: Treatment Arm Intravenous human albumin given at a maximum dose of 1g/kg at skin incision which is infused at 100ml/hour |
资格标准
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - All patients undergoing pancreaticoduodenectomy that can consent to the study Exclusion Criteria: - Patients with known allergy to human albumin - Patients of American Society of Anaesthesiologist (ASA) physical status class 3 and above. |
结果
主要结果指标
1. Overall Complications [Postoperative complications are recorded from date of surgery to date of documented complications including death, assessed from date of surgery to date of discharge or death, whichever came earlier, for up to 12 months.]
次要成果指标
1. Length of Hospital Stay [From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months]
2. Length of ICU stay [From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months]
3. Postoperative Pancreatic Fistula (POPF) rates [From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months]
4. Delayed Gastric Emptying [From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months]
5. Ease of surgery [Duration is measured from the start time till the end time of surgery and will be assessed at the end of surgery for up to 12 months]
