Acid Base ImbalanceNCT01246609
The Effect of Irrigation Solution Volume on Electrolytes and Acid-Base Balance
An observational study of Acid Base Imbalance and Percutaneous Lithotripsy, run by Rambam Health Care Campus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acid Base Imbalance, Percutaneous Lithotripsy
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is an observational prospective study of consequtive 200 adult patients undergoing elective surgery of percoutanous lithotripsy in our operating rooms.
Who may be able to join
- Adult consent patients, undergoing elective percutaneous lithotripsy.
Who cannot join
- Pregnancy
- Pre-operative acid-base imbalance
- Urgent/emergent surgery.
About this study
Official title: The Effect of Irrigation Solution Volume on Electrolytes and Acid-Base Balance in Patients Undergoing Percutaneous Lithotripsy
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.
Read more
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.
- Conditions
- Acid Base Imbalance, Percutaneous Lithotripsy
- Keywords
- acid base balance, Percutaneous Lithotripsy
- Medical subject headings
- Acid-Base Imbalance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startNov 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015
Why it stopped: the doctor who ran this study, left
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acid Base ImbalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246609
- Sponsor's protocol ID
- 0322-10CTIL
- Status last verified
- Sep 2015
- First submitted
- 22 Nov 2010
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Irrigation Solution Volume on Electrolytes and Acid-Base Balance in Patients Undergoing Percutaneous Lithotripsy
- ClinicalTrials.gov ID
- NCT01246609
- Acronym / sponsor ID
- 0322-10CTIL
- Conditions
- Acid Base Imbalance, Percutaneous Lithotripsy
- Keywords
- acid base balance, Percutaneous Lithotripsy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: the doctor who ran this study, left
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (actual)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an observational prospective study of consequtive 200 adult patients undergoing elective surgery of percoutanous lithotripsy in our operating rooms.
Key inclusion criteria (1 listed)
- Adult consent patients, undergoing elective percutaneous lithotripsy.
Key exclusion criteria (3 listed)
- Pregnancy
- Pre-operative acid-base imbalance
- Urgent/emergent surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: the doctor who ran this study, left). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acid Base Imbalance and Percutaneous Lithotripsy, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: the doctor who ran this study, left). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2015.