Effect of Crystalloids With Different SID on pH, and Urinary Electrolytes During General Anesthesia

Acid-Base Imbalance Clinical Trial

— CRYSID  

Official title:

Effect of Crystalloids With Different SID on Hemodilution, Plasmatic Acid Base Equilibrium and Urinary Electrolytes in Patients During General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03507062
• Other study ID #: 1669
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Acid-Base Imbalance
• SID

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