Acid-Base Imbalance Clinical Trial
— CRYSIDOfficial title:
Effect of Crystalloids With Different SID on Hemodilution, Plasmatic Acid Base Equilibrium and Urinary Electrolytes in Patients During General Anesthesia
NCT number | NCT03507062 |
Other study ID # | 1669 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 10, 2017 |
Est. completion date | July 30, 2023 |
Verified date | March 2024 |
Source | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | July 30, 2023 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Policlinico A. Gemelli | Roma |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Cristina Dominedò, Domenico Luca Grieco, Marco Rossi, Marta Cicetti, Massimo Antonelli, Nicoletta Filetici, Rossano Festa |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pH modification | The primary outcome of this physiological study is to evaluate, in vivo, the effect of crystalloid administration with different SID on acid base equilibrium, in particular pH variations will be considered. | Surgery | |
Secondary | Urinary SID modification (mEq/L) after crystalloids administration with different SID and chloride load | renal response to acid base disturbances caused by different crystalloid infusions and different volumes. | Surgery | |
Secondary | SID and plasmatic weak acid (A tot) variations measured in mEq/L | We will explore the changes in apparent SID (SIDapp) and effective SID (SIDeff) and strong ion gap (SIG), as well as A tot after administration of solutions with different SID | Surgery |
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