Evaluating fluid responsiveness through different methods of passive leg raising
the Impact of Manual or Mechanical Ways to Perform Passive Leg Raising on the Accuracy of Evaluation of Fluid Responsiveness
This study tests different ways of lifting patients' legs to see which method better helps doctors decide if they need more fluids during treatment for shock.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Southeast University, China Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06285331 on ClinicalTrials.gov |
What this trial studies
This study investigates how different techniques of performing passive leg raising (PLR) affect the accuracy of assessing fluid responsiveness in patients experiencing circulatory failure. Patients in shock, requiring intensive monitoring and treatment, will be evaluated for their fluid responsiveness using either manual or automatic methods of PLR. The study aims to determine which method provides a more reliable indication of a patient's need for fluid therapy, thereby improving clinical decision-making in critical care settings.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with signs of tissue hypo-perfusion who require evaluation of their fluid responsiveness and are being monitored in an intensive care setting.
Not a fit: Patients under 18 or over 75, pregnant or lactating women, and those with contraindications to passive leg raising or fluid resuscitation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of fluid responsiveness evaluations, leading to better fluid management and improved outcomes for critically ill patients.
How similar studies have performed: While the approach of evaluating fluid responsiveness through PLR is established, the specific comparison of manual versus automatic methods is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- Zhongda Hospital Southeast University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Jingyuan Xu, M.D. — Zhongda Hospital
- Study coordinator: Jingyuan Xu, M.D.
- Email: xujingyuanmail@163.com
- Phone: 8602583262550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.