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Search / Trial NCT06285331

the Impact of Manual or Mechanical Ways to Perform PLR on the Accuracy of Evaluation of Fluid Responsiveness

Launched by SOUTHEAST UNIVERSITY, CHINA · Feb 28, 2024

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Fluid Responsiveness Passive Leg Raising

ClinConnect Summary

This clinical trial is looking at how different methods of a procedure called passive leg raising (PLR) can help doctors better understand if patients with circulatory failure need more fluids. PLR involves raising a patient's legs to see how their body reacts, which can indicate whether they are responding well to fluids. The trial aims to find out if doing this manually (by hand) or mechanically (using a device) makes a difference in the accuracy of these evaluations.

To participate in the study, patients need to be between 65 and 75 years old and show signs of poor blood flow, such as increased lactate levels or low blood pressure. They must be in an intensive care unit and have a specific type of heart monitoring in place. However, those under 18 or over 75, pregnant women, or individuals unable to safely undergo PLR will not be eligible. If you choose to take part, the study will help researchers learn more about how to assess fluid needs in critically ill patients, ultimately aiming to improve care for those in similar situations.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • (1) patients who have signs of tissue hypo-perfusion (increasing lactate levels, in need of vasopressor agents to maintain blood pressure, oliguria, and weak consciousness), and need to evaluate their fluid responsiveness; (2) patients who have received Pulse indicator Continuous Cardiac Output (PiCCO) monitoring ; (3) patients who are transferred into the intensive care department.
  • Exclusion Criteria:
  • (1) Age \< 18 years old, or \> 75 years old (2) pregnancy or lactation; (3) refusal to sign the informed consent form for enrollment; (4) patients who are clearly unable to perform passive leg raising (PLR) (intra-abdominal pressure ≥16cmH2O, high risk of lower limb venous thrombosis, intracranial hypertension, and recent undergone abdominal or pelvic surgery); (5) patients with the contraindications of fluid resuscitation therapy ( pulmonary edema, intracranial hypertension and so on); (6) patients clinical doctors assessed as unsuitable for PLR.

About Southeast University, China

Southeast University, located in Nanjing, China, is a prestigious institution renowned for its commitment to advancing medical research and clinical innovation. With a strong emphasis on interdisciplinary collaboration, the university leverages its robust academic resources and state-of-the-art facilities to conduct clinical trials that aim to address pressing healthcare challenges. Southeast University actively engages in partnerships with healthcare organizations and industry leaders to facilitate cutting-edge research, enhance patient outcomes, and contribute to the global medical community. Through its dedicated focus on ethical standards and scientific rigor, Southeast University is poised to make significant contributions to the field of clinical research.

Locations

Nanjing, Jiangsu, China

Patients applied

0 patients applied

Trial Officials

Jingyuan Xu, M.D.

Principal Investigator

Zhongda Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported