Objective <p>To evaluate the feasibility and safety of a renal vein Doppler-guided central venous pressure (CVP) tritration protocol (RVD-CVP) in patients with sepsis, and to explore preliminary kidney-related and hemodynamic signals.</p> Method <p>This prospective, single-center, parallel-group pilot randomized controlled trial was conducted in an ICU between April and December 2023. Adults with sepsis and CVP monitoring were randomized 1:1 to RVD-CVP (renal vein Doppler assessments at 0, 6, 24, 48, and 72&#xa0;h with prespecified CVP targets to maintain, lower, or defer) or usual care without renal vein Doppler guidance. The primary outcome was feasibility, defined as complete protocol delivery in the intervention group. Secondary outcomes were exploratory.</p> Results <p>Of 173 screened patients, 127 were randomized (63 intervention; 64 control). Complete protocol delivery was achieved in 63/63 intervention patients (100.0%; 95% CI, 94.3–100.0), and all scheduled renal vein Doppler assessments were completed (315/315, 100.0%). Safety-override deferrals occurred in 17/315 assessments (5.4%). AKI progression within 7 days occurred in 37/64 control vs. 27/63 intervention patients (57.0% vs. 43.0%; RR 0.74, 95% CI 0.52–1.06). The intervention group also had a lower rate of renal replacement therapy (RRT) initiation and a shorter duration of RRT compared to the control group (9.52% vs. 23.44%, RR 0.41, 95% CI 0.17–0.98, <i>P</i> = 0.035; 0.84 days vs. 2.39 days, <i>P</i> = 0.03). 28-day mortality was 7.9% vs. 12.5%.&#xa0;Additionally, vasopressor-free days at day 28 were higher (mean 22.12 vs. 18.84 days) and maximum norepinephrine dose was lower (mean 0.423 vs. 0.560 µg/kg/min) in the intervention group</p> Conclusion <p>In this pilot randomized controlled trial, renal vein Doppler ultrasound–guided CVP titration was feasible and was associated with greater de-escalation and a lower fluid balance. Differences in AKI-related outcomes and renal replacement therapy use (including CRRT) were prespecified as exploratory secondary findings, and the trial was not powered to draw definitive conclusions on clinical outcomes. These signals should be interpreted cautiously and require confirmation in a larger, adequately powered randomized controlled trial.</p> <p>Clinical registration number: Register URL link:&#xa0;<a href="https://www.chictr.org.cn/">https://www.chictr.org.cn/</a>: Date:2023-12-12: Number: ChiCTR2300078565.</p>

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Impact of renal vein doppler ultrasound-guided CVP titration in sepsis: a pilot randomized controlled trial

  • Yan Huo,
  • Ming-zhe Liu,
  • Run-ying Zhu,
  • Bin Li,
  • Kun Zhang,
  • Xu-jie Zhang,
  • Jia-li Li,
  • Yan Xin,
  • Lixia Liu,
  • Zhenjie Hu,
  • Qian Zhang

摘要

Objective

To evaluate the feasibility and safety of a renal vein Doppler-guided central venous pressure (CVP) tritration protocol (RVD-CVP) in patients with sepsis, and to explore preliminary kidney-related and hemodynamic signals.

Method

This prospective, single-center, parallel-group pilot randomized controlled trial was conducted in an ICU between April and December 2023. Adults with sepsis and CVP monitoring were randomized 1:1 to RVD-CVP (renal vein Doppler assessments at 0, 6, 24, 48, and 72 h with prespecified CVP targets to maintain, lower, or defer) or usual care without renal vein Doppler guidance. The primary outcome was feasibility, defined as complete protocol delivery in the intervention group. Secondary outcomes were exploratory.

Results

Of 173 screened patients, 127 were randomized (63 intervention; 64 control). Complete protocol delivery was achieved in 63/63 intervention patients (100.0%; 95% CI, 94.3–100.0), and all scheduled renal vein Doppler assessments were completed (315/315, 100.0%). Safety-override deferrals occurred in 17/315 assessments (5.4%). AKI progression within 7 days occurred in 37/64 control vs. 27/63 intervention patients (57.0% vs. 43.0%; RR 0.74, 95% CI 0.52–1.06). The intervention group also had a lower rate of renal replacement therapy (RRT) initiation and a shorter duration of RRT compared to the control group (9.52% vs. 23.44%, RR 0.41, 95% CI 0.17–0.98, P = 0.035; 0.84 days vs. 2.39 days, P = 0.03). 28-day mortality was 7.9% vs. 12.5%. Additionally, vasopressor-free days at day 28 were higher (mean 22.12 vs. 18.84 days) and maximum norepinephrine dose was lower (mean 0.423 vs. 0.560 µg/kg/min) in the intervention group

Conclusion

In this pilot randomized controlled trial, renal vein Doppler ultrasound–guided CVP titration was feasible and was associated with greater de-escalation and a lower fluid balance. Differences in AKI-related outcomes and renal replacement therapy use (including CRRT) were prespecified as exploratory secondary findings, and the trial was not powered to draw definitive conclusions on clinical outcomes. These signals should be interpreted cautiously and require confirmation in a larger, adequately powered randomized controlled trial.

Clinical registration number: Register URL link: https://www.chictr.org.cn/: Date:2023-12-12: Number: ChiCTR2300078565.