Effect of Crystalloids With Different SID on pH, and Urinary Electrolytes During General Anesthesia (NCT03507062) | Clinical Trial Compass
CompletedNot Applicable
Effect of Crystalloids With Different SID on pH, and Urinary Electrolytes During General Anesthesia
Italy45 participantsStarted 2017-12-10
Plain-language summary
The present study will investigate variations in acid base equilibrium caused by the administration of four different crystalloids with increasing strong ion difference (0.9% saline, Ringer's lactate, Ringer's acetate, plasmalyte-like solution) in patients during general anesthesia.
The same crystalloid will be administered throughout the surgery. In order to assess the effect of hemodilution, every patient will receive two fluid boli with different volumes of the same solution. pH and strong ion variations, togher with the renal response to acid base disturbances, will be analysed.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients (between 18 and 75 years old);
* ASA (American Society of Anesthesiologists) physical status classification system 1 or 2;
* Patients undergoing spinal surgery under general anesthesia, intubated and mechanically ventilated;
* Normal preoperative albumin;
* Surgery with an estimated duration of at least 3 hours.
Exclusion Criteria:
* Patients who are pregnant;
* Patients with obesity (BMI \> 35);
* Patients with a chronic obstructive pulmonary disease (COPD);
* Patients with obstructive sleep apnea (OSA) treated with CPAP;
* Patients with chronic heart failure (CHF) with a NYHA (New York Heart Association) class ≥2;
* Patients receiving diuretics in the pre-operative period;
* Patients with a chronic kidney disease (CKD), defined as a GFR \< 60 ml/min/1.73 m2;
* Patients with diabetes mellitus treated with insulin;
* Patients with myopathies; Patients undergoing a surgery with likely fluid losses or with unexpected bleeding during surgery.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.