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

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Completed

Conditions

Acid-Base Imbalance
SID

Treatments

Other: Ringer's lactate administration
Other: 0.9% saline administration
Other: Plasmalyte-like solution administration

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

45 participants in 3 patient groups

Chloride-rich solution
Experimental group
Description:
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.
Treatment:
Other: 0.9% saline administration
Low-chloride solution A
Experimental group
Description:
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.
Treatment:
Other: Ringer's lactate administration
Very low-chloride solution
Experimental group
Description:
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.
Treatment:
Other: Plasmalyte-like solution administration

Trial contacts and locations

1

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Central trial contact

Antonio M Dell'Anna, MD

Data sourced from clinicaltrials.gov

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