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

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

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.

Study Overview

• Status: Completed
• Conditions: Acid-Base Imbalance; SID
• Intervention / Treatment: Other: 0.9% saline administration; Other: Ringer's lactate administration; Other: Plasmalyte-like solution administration

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico A. Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chloride-rich solution; Patients will receive two boluses of 10 and 20 ml/kg of the 0.9% saline in two different moments after at least 1 hour from each other. Plasma arterial blood gas (ABG) and electrolytes, along with plasmatic creatinine, albumin and phosphate will be measured immediately before and five minutes after fluid boluses. Urinary electrolytes (Na, K, Cl) will be measured immediately before fluid bolus and after one hour from fluid administration along with ABG and plasmatic electrolytes and creatinine, phosphate and albumin.	Other: 0.9% saline administration; Each patient will receive 0.9%saline based on attending physician decision
Experimental: Low-chloride solution A; Patients will receive two boluses of 10 and 20 ml/kg of Ringer's lactate in two different moments after at least 1 hour from each other. Plasma arterial blood gas (ABG) and electrolytes, along with plasmatic creatinine, albumin and phosphate will be measured immediately before and five minutes after fluid boluses. Urinary electrolytes (Na, K, Cl) will be measured immediately before fluid bolus and after one hour from fluid administration along with ABG and plasmatic electrolytes and creatinine, phosphate and albumin.	Other: Ringer's lactate administration; Each patient will receive Ringer's lactate based on attending physician decision
Experimental: Very low-chloride solution; Patients will receive two boluses of 10 and 20 ml/kg of a plasmalyte-like solution (namely soluzione elettrolitica reintegrante [SER]) in two different moments after at least 1 hour from each other. Plasma arterial blood gas (ABG) and electrolytes, along with plasmatic creatinine, albumin and phosphate will be measured immediately before and five minutes after fluid boluses. Urinary electrolytes (Na, K, Cl) will be measured immediately before fluid bolus and after one hour from fluid administration along with ABG and plasmatic electrolytes and creatinine, phosphate and albumin.	Other: Plasmalyte-like solution administration; Each patient will receive Plasmalyte-like solution based on attending physician decision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Collaborators: Massimo Antonelli; Cristina Dominedò; Marco Rossi; Rossano Festa; Nicoletta Filetici; Marta Cicetti; Domenico Luca Grieco
• Investigators: Principal Investigator: Antonio M Dell'Anna, MD, Fondazione Policlinico A. Gemelli

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2017
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: April 14, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: pH; crystalloids
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Pharmaceutical Solutions; Ophthalmic Solutions; Plasma-lyte 148
• Other Study ID Numbers: 1669

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No