scholarly journals Protocol and statistical analysis plan for the REstricted fluid therapy VERsus Standard trEatment in Acute Kidney Injury—REVERSE‐AKI randomized controlled pilot trial

2020 ◽  
Vol 64 (6) ◽  
pp. 831-838
Author(s):  
Suvi T. Vaara ◽  
Marlies Ostermann ◽  
Tuomas Selander ◽  
Laurent Bitker ◽  
Antoine Schneider ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Statistical Analysis ◽  
Fluid Therapy ◽  
Standard Treatment ◽  
Pilot Trial ◽  
Kidney Injury ◽  
Statistical Analysis Plan ◽  
Randomized Controlled

scholarly journals Impact of goal-directed hemodynamic management on the incidence of acute kidney injury in patients undergoing partial nephrectomy: a pilot randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Qiong-Fang Wu ◽  
Hao Kong ◽  
Zhen-Zhen Xu ◽  
Huai-Jin Li ◽  
Dong-Liang Mu ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Partial Nephrectomy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Kidney Injury ◽  
Control Group ◽  
Hemodynamic Management ◽  
Randomized Controlled ◽  
Renal Hilum ◽  
Pilot Randomized Controlled Trial

Abstract Background The incidence of acute kidney injury (AKI) remains high after partial nephrectomy. Ischemia-reperfusion injury produced by renal hilum clamping during surgery might have contributed to the development of AKI. In this study we tested the hypothesis that goal-directed fluid and blood pressure management may reduce AKI in patients following partial nephrectomy. Methods This was a pilot randomized controlled trial. Adult patients who were scheduled to undergo partial nephrectomy were randomized into two groups. In the intervention group, goal-directed hemodynamic management was performed from renal hilum clamping until end of surgery; the target was to maintain stroke volume variation < 6%, cardiac index 3.0–4.0 L/min/m2 and mean arterial pressure > 95 mmHg with crystalloid fluids and infusion of dobutamine and/or norepinephrine. In the control group, hemodynamic management was performed according to routine practice. The primary outcome was the incidence of AKI within the first 3 postoperative days. Results From June 2016 to January 2017, 144 patients were enrolled and randomized (intervention group, n = 72; control group, n = 72). AKI developed in 12.5% of patients in the intervention group and in 20.8% of patients in the control group; the relative reduction of AKI was 39.9% in the intervention group but the difference was not statistically significant (relative risk 0.60, 95% confidence interval [CI] 0.28–1.28; P = 0.180). No significant differences were found regarding AKI classification, change of estimated glomerular filtration rate over time, incidence of postoperative 30-day complications, postoperative length of hospital stay, as well as 30-day and 6-month mortality between the two groups. Conclusion For patients undergoing partial nephrectomy, goal-directed circulatory management during surgery reduced postoperative AKI by about 40%, although not significantly so. The trial was underpowered. Large sample size randomized trials are needed to confirm our results. Trial registration Clinicaltrials.gov identifier: NCT02803372. Date of registration: June 6, 2016.

scholarly journals Statistical analysis plan for the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) trial: a randomized controlled trial of a specialist palliative care intervention for patients undergoing surgery for cancer

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Onur M. Orun ◽  
Myrick C. Shinall ◽  
Aimee Hoskins ◽  
Ellis Morgan ◽  
Mohana Karlekar ◽  
...  
Keyword(s):  
Palliative Care ◽  
Randomized Controlled Trial ◽  
Statistical Analysis ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Specialist Palliative Care ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Scope Trial

Abstract Background The impact of specialist palliative care intervention in patients undergoing surgery for cancer has not been studied extensively. The SCOPE randomized controlled trial will investigate the effect of specialist palliative care intervention in cancer patients undergoing surgery for selected abdominal malignancies. The study protocol of the SCOPE Trial was published in December 2019. Methods and design The SCOPE Trial is a single-center, single-blind, prospective, randomized controlled trial that will investigate specialist palliative care intervention for cancer patients undergoing surgery for selected abdominal malignancies. The study plans to enroll 236 patients that will be randomized to specialist palliative care (intervention arm) and usual care (control arm) in a 1:1 ratio. Results The primary outcome of the study is the Functional Assessment of Cancer Therapy-General (FACT-G) Trial Outcome Index (TOI) at 90 days postoperatively. Secondary outcomes of the study include the total FACT-G score at 90 days postoperatively, days alive at home without an emergency room visit within 90 days of operation, and all-cause mortality at 1 year after operation. Time frames for all outcomes will start on the day of surgery. Conclusion This manuscript serves as the formal statistical analysis plan (version 1.0) for the SCOPE randomized controlled trial. The statistical analysis plan was completed on 6 April 2021. Trial registration ClinicalTrials.gov NCT03436290. Registered on 16 February 2018

scholarly journals Restrictive versus Liberal Fluid Therapy for Post-Cesarean Acute Kidney Injury in Severe Preeclampsia: a Pilot Randomized Clinical Trial

Clinics ◽  
2020 ◽  
Vol 75 ◽  
Author(s):  
Wallace Andrino da Silva ◽  
Carlo Victor A. Varela ◽  
Aline Macedo Pinheiro ◽  
Paula Castro Scherer ◽  
Rossana P.V. Francisco ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Acute Kidney Injury ◽  
Randomized Clinical Trial ◽  
Fluid Therapy ◽  
Kidney Injury ◽  
Severe Preeclampsia
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