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

NCT03507062 | Completed

• 1 other identifier: 1669
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

SID; Acid-Base Imbalance

Keywords

pH; crystalloids

Outcome Measures

Primary Outcomes (1)

• 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.

  Surgery

Secondary Outcomes (2)

• Urinary SID modification (mEq/L) after crystalloids administration with different SID and chloride load

  Surgery

• SID and plasmatic weak acid (A tot) variations measured in mEq/L

  Surgery

Study Arms (3)

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.

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.

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.

Other: Plasmalyte-like solution administration

Interventions

0.9% saline administration OTHER

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

Chloride-rich solution

Ringer's lactate administration OTHER

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

Low-chloride solution A

Plasmalyte-like solution administration OTHER

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

Very low-chloride solution

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Cristina Dominedò: collaborator
• Marco Rossi: collaborator
• Rossano Festa: collaborator
• Nicoletta Filetici: collaborator
• Marta Cicetti: collaborator
• Domenico Luca Grieco: collaborator
• Massimo Antonelli: collaborator

Study Sites (1)

Fondazione Policlinico A. Gemelli

Roma, 00168, Italy

Location

Related Publications (1)

• 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.

  PMID: 40263186 DERIVED

MeSH Terms

Conditions

Sudden Infant Death; Acid-Base Imbalance

Condition Hierarchy (Ancestors)

Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant Death; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Antonio M Dell'Anna, MD

  Fondazione Policlinico A. Gemelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: April 24, 2018
• Study Start: December 10, 2017
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)