Acid Base Imbalance Clinical Trial
Official title:
The Effect of Irrigation Solution Volume on Electrolytes and Acid-Base Balance in Patients Undergoing Percutaneous Lithotripsy
| Verified date | September 2015 |
| Source | Rambam Health Care Campus |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ethics Commission |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 1 |
| Est. completion date | September 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Adult consent patients, undergoing elective percutaneous lithotripsy. Exclusion Criteria: - Pregnancy - Pre-operative acid-base imbalance - Urgent/emergent surgery. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Rambam Health Care Campus |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01087853 -
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|
Phase 1/Phase 2 | |
| Completed |
NCT02691676 -
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|
Phase 3 |