SIDCRYSIDNCT03507062

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

A study testing 0.9% saline administration, Ringer's lactate administration and Plasmalyte-like solution administration in people with SID and Acid-Base Imbalance, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: SID, Acid-Base Imbalance
What is being tested?: 0.9% saline administration, Ringer's lactate administration and Plasmalyte-like solution administration
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteItaly
Study dates: 10 Dec 2017to 30 Jul 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Fondazione Policlinico A. Gemelli
Roma, 00168

Other trials in Italy

About this study

Official title: Effect of Crystalloids With Different SID on Hemodilution, Plasmatic Acid Base Equilibrium and Urinary Electrolytes 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.

Conditions: SID, Acid-Base Imbalance
Being tested: 0.9% saline administration, Ringer's lactate administration, Plasmalyte-like solution administration
Keywords: pH, crystalloids
Medical subject headings: Sudden Infant Death, Acid-Base Imbalance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03507062
Study group	Role	What they receive
Chloride-rich solution	Experimental	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. Receives: Other: 0.9% saline administration
Low-chloride solution A	Experimental	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. Receives: Other: Ringer's lactate administration
Very low-chloride solution	Experimental	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. Receives: Other: Plasmalyte-like solution administration

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Surgery

Secondary outcomes (2)

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.
Measured: 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
Measured: Surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Dec 201730 Jul 2023

First posted24 Apr 2018
Study start10 Dec 2017
Primary completion30 Jun 2022
Study completion30 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SIDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03507062
Sponsor's protocol ID: 1669
Acronym: CRYSID
Status last verified: Mar 2024
First submitted: 15 Mar 2018
Last updated: 26 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Dell'Anna AM, Grieco DL, Dominedo C, Cicetti M, Cisterna I, Festa R, Lamacchia R, Gianni G, Filetici N, Michi T, Rossi C, Alcaro FD, Mele A, Rocchi A, Del Prete D, Meluzio MC, Tamburrelli FC, Rossi M, Antonelli M. Stewart's theory and acid-base changes induced by crystalloid infusion in humans: a randomized physiological trial. Ann Intensive Care. 2025 Apr 22;15(1):54. doi: 10.1186/s13613-025-01473-9.
PubMed 40263186

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
A Study of Secondary Immunodeficiencies in Adults With Blood Cancers in Kazakhstan Who Have a Weakened Immune System (K-SIDE Study)
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Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency
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Assessing Patient Preference for Infusion Systems
Primary Immunodeficiencies (PID), Secondary Immunodeficiencies (SID)
RecruitingObservational study
Developing a Patient-Reported Outcome (PRO) Screening Measure for Infections and Measuring Quality of Life in Hematological Patients With Secondary Immunodeficiency (SID) Across the Treatment Trajectory - The PRO SID Project
Chronic Lymphocytic Leukaemia (CLL), Multiple Myeloma (MM)

All SID trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Crystalloids With Different SID on Hemodilution, Plasmatic Acid Base Equilibrium and Urinary Electrolytes in Patients During General Anesthesia
ClinicalTrials.gov ID: NCT03507062
Acronym / sponsor ID: CRYSID / 1669
Conditions: SID, Acid-Base Imbalance
Keywords: pH, crystalloids
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
Collaborators: Cristina Dominedò, Marco Rossi, Rossano Festa, Nicoletta Filetici, Marta Cicetti, Domenico Luca Grieco, Antonelli, Massimo, M.D.
Study start: 10 Dec 2017 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 30 Jul 2023 (actual)
First posted: 24 Apr 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Chloride-rich solution	Experimental	Other: 0.9% saline administrationPatients 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.
Low-chloride solution A	Experimental	Other: Ringer's lactate administrationPatients 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.
Very low-chloride solution	Experimental	Other: Plasmalyte-like solution administrationPatients 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
0.9% saline administrationEach patient will receive 0.9%saline based on attending physician decision	Other	Chloride-rich solution
Ringer's lactate administrationEach patient will receive Ringer's lactate based on attending physician decision	Other	Low-chloride solution A
Plasmalyte-like solution administrationEach patient will receive Plasmalyte-like solution based on attending physician decision	Other	Very low-chloride solution

Primary outcome

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.

2 secondary outcomes

Urinary SID modification (mEq/L) after crystalloids administration with different SID and chloride load
Time frame: Surgery
SID and plasmatic weak acid (A tot) variations measured in mEq/L
Time frame: Surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
Derived from this study: PubMed 40263186Dell'Anna AM, Grieco DL, Dominedo C, Cicetti M, Cisterna I, Festa R, Lamacchia R, Gianni G, Filetici N, Michi T, Rossi C, Alcaro FD, Mele A, Rocchi A, Del Prete D, Meluzio MC, Tamburrelli FC, Rossi M, Antonelli M. Stewart's theory and acid-base changes induced by crystalloid infusion in humans: a randomized physiological trial. Ann Intensive Care. 2025 Apr 22;15(1):54. doi: 10.1186/s13613-025-01473-9.
Individual participant dataSharing planned: No

Related trials for SID

Not yet recruitingObservational study
A Study of Secondary Immunodeficiencies in Adults With Blood Cancers in Kazakhstan Who Have a Weakened Immune System (K-SIDE Study)
Secondary Immunodeficiency (SID)
Not yet recruitingObservational study
Supply Induced Demand in Intensive Care Unit: a Retrospective Trial
Intensive Care (ICU), Intensive Care Unit (ICU) Admission
RecruitingObservational study
Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency
Multiple Myeloma, Secondary Immunodeficiency (SID)
Not yet recruiting
Assessing Patient Preference for Infusion Systems
Primary Immunodeficiencies (PID), Secondary Immunodeficiencies (SID)
RecruitingObservational study
Developing a Patient-Reported Outcome (PRO) Screening Measure for Infections and Measuring Quality of Life in Hematological Patients With Secondary Immunodeficiency (SID) Across the Treatment Trajectory - The PRO SID Project
Chronic Lymphocytic Leukaemia (CLL), Multiple Myeloma (MM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Antonio M Dell'Anna, MD principal investigator

Fondazione Policlinico A. Gemelli

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pH modification (time frame: Surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03507062, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024; AzTrials last refreshed its copy on 29 Oct 2026.