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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2024
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
0.9% saline administration
Each patient will receive 0.9%saline based on attending physician decision
Ringer's lactate administration
Each patient will receive Ringer's lactate based on attending physician decision
Plasmalyte-like solution administration
Each patient will receive Plasmalyte-like solution based on attending physician decision

Locations

Country Name City State
Italy Fondazione Policlinico A. Gemelli Roma

Sponsors (8)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Cristina Dominedò, Domenico Luca Grieco, Marco Rossi, Marta Cicetti, Massimo Antonelli, Nicoletta Filetici, Rossano Festa

Country where clinical trial is conducted

Italy, 

Outcome

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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