Trial reportMedicine2020
Intraoperative fluid management in hepato-biliary-pancreatic operation using stroke volume variation monitoring: A single-center, open-label, randomized pilot study.
Trial report in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.
- Goal-directed haemodynamic therapy during general anaesthesia for noncardiac surgery: a systematic review and meta-analysis.British journal of anaesthesia · 2022Pooled it
- Article
- Current Commonly Used Dynamic Parameters and Monitoring Systems for Perioperative Goal-Directed Fluid Therapy: A Review.The Yale journal of biology and medicine · 2023Review
- A Single-Center Retrospective Study of Selected Clinical Parameters and Intraoperative Fluid Management of Patients Undergoing Pancreatoduodenectomy.Medical science monitor : international medical journal of experimental and clinical research · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
TRIAL
designThis investigator-initiated, single-center, open-label, parallel-group, randomized-controlled pilot study was designed to compare the intraoperative fluid balance and perioperative complications in patients undergoing hepato-biliary-pancreatic surgery with or without stroke volume variation (SVV)-guided fluid management.
methodsPatients who were aged >18 years and underwent elective major hepato-biliary-pancreatic surgery between June 30, 2015, and August 31, 2016 at our center were randomly assigned to receive SVV-guided or conventional fluid therapy. The intervention group used SVV to determine the patients' volume status. The primary outcome was the total fluid balance per body weight per operation time, and the secondary outcomes were the total amount of intravenous infusion per body weight per operation time and the Sequential Organ Failure Assessment score on postoperative day 1. Patients were randomized by a two-block computer-generated assignment sequence. Masking of patients and assessors was conducted. The patients and assessors were each blinded to the details of the trial; however, the clinicians were not.
resultsOf the 69 patients who were initially eligible, 60 provided informed consent for participation in the study. After randomization, three patients dropped out of the study because of deviations from the protocol or unexpected hypotension, leaving 28 and 29 patients in the intervention and control groups, respectively. Patients in both groups had similar characteristics at baseline. The median (interquartile range [IQR]) intraoperative fluid balance in the control and SVV groups was 6.2 (IQR, 4.9-7.9) and 8.1 (IQR, 5.7-10.5) ml/kg/h, respectively (P = .103). The administered intravenous infusion was significantly higher in the SVV group (median, 10.9; IQR, 8.3-15.3 ml/kg/h) than in the control group (median, 9.5; IQR, 7.7-10.3 ml/kg/h) (P = .011). On postoperative day 1, the PaO2/FiO2 ratio was lower in the SVV group (median, 266; IQR, 261-341) than in the control group (median, 346; IQR, 299-380) (P = .019).
conclusionsUse of the SVV-guided fluid management protocol did not reduce intraoperative fluid balance but increased the intraoperative fluid administration and might worsen postoperative oxygenation.
trial registrationUMIN000018111.
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