The Effect of Irrigation Solution Volume on Electrolytes and Acid-Base Balance

Sponsor
Rambam Health Care Campus (Other)
Overall Status
Terminated
CT.gov ID
NCT01246609
Collaborator
(none)
1
10

Study Details

Study Description

Brief Summary

Background:

There are several surgical procedures in which irrigation fluids are used to enable vision and treatment in body cavities, such as hysteroscopy, arthroscopy and cystoscopy. Several solutions are used for irrigation: normal saline, glycin, mannitol, sorbitol and others. Post-operative complications, as visual disturbances, confusion and other neurologic symptoms were attributed to irrigation fluid absorption, water intoxication and hyponatremia, and are refered to as "TURP syndrome" when appearing following transurethral prostatectomy (TURP). Historically, a reduced serum sodium concentration has been used to diagnose absorption of electrolytes-free irrigating fluid during urologic procedures. However, neurologic symptoms following transurethral prostatectomy (TURP) do not correlate with blood sodium level, moreover, Hyponatremia may not be the sole or even the primary cause of the neurological manifestations of TURP syndrome. Other techniques were suggested for evaluating the volume of irrigation solution absorption though none is used routinely in the clinical setting.

Percutaneous Lithotripsy (PCNL) is a procedure used to treat patients with nephrolithiasis. In this procedure irrigation fluid is administered into the kidney and urinary tract collecting system. The solution used is normal saline. In earlier studies there was no evidence for absorption of the irrigation fluids, though medical literature on this issue is limited. However, minute changes in electrolytes and acid-base balance may indicate the opposite is true. Indeed, the volume of irrigation and duration of the procedure may have an effect as well. According to the investigators hypothesis, the change in Ph and reduction in base content in patients undergoing PCNL may be the result of irrigation fluid absorption, since chloride from the normal saline is known to cause such effect.

Methods This is an observational prospective study of consecutive 200 adult patients undergoing elective surgery of PCNL in the investigators operating rooms.

The investigators will collect data that is taken from the patient's file and routine management of these patients: age, gender, weight, pre-operative blood tests including: electrolytes, creatinine, hematocrit, ph, bicarbonate, base, length of the procedure, volume and type of irrigation fluids used, volume and type of intravenous fluids used. Post-operative blood tests will be recorded.

The investigators will compare pre and post-operative blood tests, especially ph, bicarbonate, base content, sodium. The investigators will analyse statistically the correlation between the change of each parameter (delta X) and the volume of irrigation fluids used during the surgery.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Effect of Irrigation Solution Volume on Electrolytes and Acid-Base Balance in Patients Undergoing Percutaneous Lithotripsy
    Study Start Date :
    Nov 1, 2014
    Anticipated Primary Completion Date :
    Sep 1, 2015
    Actual Study Completion Date :
    Sep 1, 2015

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 80 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Adult consent patients, undergoing elective percutaneous lithotripsy.
      Exclusion Criteria:
      • Pregnancy

      • Pre-operative acid-base imbalance

      • Urgent/emergent surgery.

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Rambam Health Care Campus

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Rambam Health Care Campus
      ClinicalTrials.gov Identifier:
      NCT01246609
      Other Study ID Numbers:
      • 0322-10CTIL
      First Posted:
      Nov 23, 2010
      Last Update Posted:
      Sep 9, 2015
      Last Verified:
      Sep 1, 2015
      Keywords provided by Rambam Health Care Campus
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Sep 9, 2015