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

March 25, 2024 updated by: Antonio Maria Dell'Anna, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pH modification
Time Frame: Surgery
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Urinary SID modification (mEq/L) after crystalloids administration with different SID and chloride load
Time Frame: Surgery
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
Time Frame: Surgery
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Massimo Antonelli
Cristina Dominedò
Marco Rossi
Rossano Festa
Nicoletta Filetici
Marta Cicetti
Domenico Luca Grieco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Antonio M Dell'Anna, MD, Fondazione Policlinico A. Gemelli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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