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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03507062

Acronym

CRYSID

Enrollment

Registered

2018-04-24

Start date

2017-12-10

Completion date

2023-07-30

Last updated

2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acid-Base Imbalance, SID

Keywords

pH, crystalloids

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.

Interventions

OTHER0.9% saline administration

Each patient will receive 0.9%saline based on attending physician decision

OTHERRinger's lactate administration

Each patient will receive Ringer's lactate based on attending physician decision

OTHERPlasmalyte-like solution administration

Each patient will receive Plasmalyte-like solution based on attending physician decision

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
pH modification	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.

Secondary

Measure	Time frame	Description
Urinary SID modification (mEq/L) after crystalloids administration with different SID and chloride load	Surgery	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	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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026