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

Not Applicable

Completed

• Conditions: SID; Acid-Base Imbalance
• Interventions: Other: 0.9% saline administration; Other: Ringer's lactate administration; Other: Plasmalyte-like solution administration

• Registration Number: NCT03507062
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-10
• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-04-14
• Study First Posted: 2018-04-24
• Primary Completion: 2022-06-30
• Study Completion: 2023-07-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chloride-rich solution	0.9% saline administration	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.
Low-chloride solution A	Ringer's lactate administration	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.
Very low-chloride solution	Plasmalyte-like solution administration	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Fondazione Policlinico A. Gemelli; 🇮🇹 Roma, Italy