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

Primary Purpose

SID, Acid-Base Imbalance

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
0.9% saline administration
Ringer's lactate administration
Plasmalyte-like solution administration
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for SID focused on measuring pH, crystalloids

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fondazione Policlinico A. Gemelli

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Chloride-rich solution

Low-chloride solution A

Very low-chloride solution

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
March 15, 2018
Last Updated
September 18, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
Cristina Dominedò, Marco Rossi, Rossano Festa, Nicoletta Filetici, Marta Cicetti, Domenico Luca Grieco, Massimo Antonelli
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1. Study Identification

Unique Protocol Identification Number
NCT03507062
Brief Title
Effect of Crystalloids With Different SID on pH, and Urinary Electrolytes During General Anesthesia
Acronym
CRYSID
Official Title
Effect of Crystalloids With Different SID on Hemodilution, Plasmatic Acid Base Equilibrium and Urinary Electrolytes in Patients During General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 10, 2017 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
Cristina Dominedò, Marco Rossi, Rossano Festa, Nicoletta Filetici, Marta Cicetti, Domenico Luca Grieco, Massimo Antonelli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SID, Acid-Base Imbalance
Keywords
pH, crystalloids

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chloride-rich solution
Arm Type
Experimental
Arm Description
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.
Arm Title
Low-chloride solution A
Arm Type
Experimental
Arm Description
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.
Arm Title
Very low-chloride solution
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
0.9% saline administration
Intervention Description
Each patient will receive 0.9%saline based on attending physician decision
Intervention Type
Other
Intervention Name(s)
Ringer's lactate administration
Intervention Description
Each patient will receive Ringer's lactate based on attending physician decision
Intervention Type
Other
Intervention Name(s)
Plasmalyte-like solution administration
Intervention Description
Each patient will receive Plasmalyte-like solution based on attending physician decision
Primary Outcome Measure Information:
Title
pH modification
Description
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.
Time Frame
Surgery
Secondary Outcome Measure Information:
Title
Urinary SID modification (mEq/L) after crystalloids administration with different SID and chloride load
Description
renal response to acid base disturbances caused by different crystalloid infusions and different volumes.
Time Frame
Surgery
Title
SID and plasmatic weak acid (A tot) variations measured in mEq/L
Description
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
Time Frame
Surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio M Dell'Anna, MD
Organizational Affiliation
Fondazione Policlinico A. Gemelli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Policlinico A. Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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