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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-10

Study Completion Date

2023-07-30

Brief Summary

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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.

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Detailed Description

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Conditions

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SID Acid-Base Imbalance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

0.9% saline administration

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Ringer's lactate administration

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Plasmalyte-like solution administration

Intervention Type OTHER

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

Interventions

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0.9% saline administration

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

Intervention Type OTHER

Ringer's lactate administration

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

Intervention Type OTHER

Plasmalyte-like solution administration

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No