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Completed

NCT Number: NCT03507062

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

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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Key information

Conditions

SID Acid-Base Imbalance Death Death, Sudden Infant Death Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Infant Death

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico A. Gemelli

Roma, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.9% saline administration

Other

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

Ringer's lactate administration

Other

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

Plasmalyte-like solution administration

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: Surgery

    renal response to acid base disturbances caused by different crystalloid infusions and different volumes.

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Cristina Dominedò
  • Domenico Luca Grieco
  • Marco Rossi
  • Marta Cicetti
  • Massimo Antonelli
  • Nicoletta Filetici
  • Rossano Festa

Registry information

Official study title

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

Acronym: CRYSID

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Apr 24, 2018
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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