Hyperchloremic AcidosisNCT05285189
Effects of Isotonic Saline As Irrigation Fluid In Transurethral Resection of Prostate (TUR-P) Operations
An observational study of Hyperchloremic Acidosis and Transurethral Resection of Prostate, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Benign hypertrophy of the prostate (BPH) is a disease seen in 20% of men over the age of 50 and in 40% of those over the age of 70. The gold standard in the treatment of BPH is transurethral resection of the prostate using high-frequency diathermy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hyperchloremic Acidosis, Transurethral Resection of Prostate, Normal Anion Gap Metabolic Acidosis
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 31 Jul 2022
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: * Male gender who being prostate hyperplasia * Having had a TUR-P operation * Using of bipolar technic * American Society of Anesthesiology (ASA) grade I-III * Receiving patients consent
Who may be able to join
- Male gender
- Having had a TUR-P operation
- Using of bipolar technic
- American Society of Anesthesiology (ASA) grade I-III
- Receiving patients consent
Who cannot join
- Failure to record preoperative and postoperative blood gas data
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University
Istanbul, 34093
Meltem Savran Karadeniz, Assoc.Prof.
About this study
Official title: The Effects of Isotonic Saline as Irrigation Fluid on Serum Electrolytes and Blood Gases in Bipolar Transurethral Resection of Prostate (TUR-P) : A Prospective Observational Study
Benign hypertrophy of the prostate (BPH) is a disease seen in 20% of men over the age of 50 and in 40% of those over the age of 70. The gold standard in the treatment of BPH is transurethral resection of the prostate using high-frequency diathermy. Today, this process is done with the bipolar technique, in which isotonic saline (isotonic sodium chloride %0.9) is used as the irrigation fluid. This irrigation fluid, which is used after long operation and deep tissue resection, can enter the systemic circulation through the opened venous sinuses.
It has been shown in clinical studies that postoperative acute hyperchloremia (serum Cl level > 110 mmol/L) develops after the use of intravenous normal saline solution in large amounts in the perioperative period.
Read more
Our aim is to detect hyperchloremia and associated metabolic acidosis without anion gap in the follow-up of these patients. Our primary hypothesis in this study is that hyperchloremic metabolic acidosis will develop due to the high amount of normal saline used in TUR-P.
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Read the detailed description
Benign hypertrophy of the prostate (BPH) is a disease seen in 20% of men over the age of 50 and in 40% of those over the age of 70. The gold standard in the treatment of BPH is transurethral resection of the prostate using high-frequency diathermy. Today, this process is done with the bipolar technique, in which normal saline (isotonic sodium chloride %0.9) is used as the irrigation fluid. In bipolar TUR-P, resection is performed using 25000 - 30000 ml normal saline for irrigation. This irrigation fluid, which is used after long operation and deep tissue resection, can enter the systemic circulation through the opened venous sinuses.
It has been shown in clinical studies that postoperative acute hyperchloremia (serum Cl level > 110 mmol/L) develops after the use of intravenous normal saline solution in large amounts in the perioperative period. McCluskey et al. found that 30-day mortality, prolonged hospital stay, and postoperative renal dysfunction developed in patients who received perioperative intravenous normal saline and subsequently developed acute hyperchloremia. Megan E. et al. Scheingraber et al. reported that the use of normal saline increases the risk of acidosis and kidney damage, also compared Ringer's lactate and normal saline infusion in patients who underwent gynecological surgery and showed that hyperchloremic metabolic acidosis developed in normal saline group. Excessive and rapid administration of normal saline solution by parenteral route causes hyperchloremic metabolic acidosis, which adversely affects the organism. According to recent studies, the development of hyperchloremic metabolic acidosis increases the cost and mortality, prolongs the hospitalization period, and causes renal dysfunction.
Our aim is to detect hyperchloremia and associated metabolic acidosis without anion gap in the follow-up of these patients. Our primary hypothesis in this study is that hyperchloremic metabolic acidosis will develop due to the high amount of normal saline used in TUR-P.
The investigators expect that an increase in the amount of fluid, prolongation of the operation time, and capsule perforation will increase hyperchloremia and deepen metabolic acidosis. If it causes hyperchloremic metabolic acidosis, the contribution of the amount of irrigation fluid or the duration of the operation can be determined, and the maximum amount of fluid that does not adversely affect the organism and the duration of the operation can be predicted.
- Conditions
- Hyperchloremic Acidosis, Transurethral Resection of Prostate, Normal Anion Gap Metabolic Acidosis, Anesthesia
- Keywords
- Blood gas analysis, TUR-P, Irrigation Fluid, Hyperchloremia
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Chlorid level
Chlorid level is evaluated with blood gas analysis 3 times in total, at the beginning of the operation, at the 40th minute of the operation and 1st hour of arrival in post-anesthesia care unit.
Measured: Up to 4 hours
Secondary outcomes (11)
Serum anion gap level
It is evaluated with blood gas analysis 3 times in total, at the beginning of the operation, at the 40th minute of the operation and 1st hour of arrival in post-anesthesia care unit.
Measured: Up to 4 hours
Serum lactate level
It is evaluated with blood gas analysis 3 times in total, at the beginning of the operation, at the 40th minute of the operation and 1st hour of arrival in post-anesthesia care unit.
Measured: Up to 4 hours
Presence&absence of capsule perforation during the operation
Effect of capsule perforation on hyperchloremia
Measured: Up to 4 hours
Amount of prostate tissue resected during the operation
The effect of the amount of prostate tissue resected during the operation on hyperchloremia.
Measured: Up to 4 hours
Amount of used normal saline for irrigation during the operation
The effect of the amount of used normal saline for irrigation during the operation on hyperchloremia.
Measured: Up to 4 hours
Duration of operation
The effect of operation time on hyperchloremia.
Measured: Up to 4 hours
Incidence of postoperative acute kidney injury
AKI was diagnosed by an increase in serum creatinine concentration >50% from a baseline creatinine concentration measured within 48 hours prior to enrollment
Measured: Up to 48 hours
Incidence of mortality rate
Mortality of the patients was screened retrospectively at 6 months postoperatively.
Measured: Up to 6 months
Length of hospital stay
Length of patients hospital stay was screened retrospectively at 1 week postoperatively.
Measured: Up to 1 week
Number of participants with urethral stricture
Diagnosis will be made by urethroscopy in patients with voiding complaints.
Measured: Up to 6 months
Number of participants with urinary bladder hematoma
Urinary system ultrasound in patients with severe hematuria
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Jan 2019
- Primary completion29 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hyperchloremic AcidosisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Savran Karadeniz, Istanbul University
- Investigators
- Meltem Savran Karadeniz, Assoc.Prof., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285189
- Sponsor's protocol ID
- 2018/1378
- Status last verified
- Mar 2022
- First submitted
- 9 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barker ME. 0.9% saline induced hyperchloremic acidosis. J Trauma Nurs. 2015 Mar-Apr;22(2):111-6. doi: 10.1097/JTN.0000000000000115.
PubMed 25768968Dombre V, De Seigneux S, Schiffer E. [Sodium chloride 0.9%: nephrotoxic crystalloid?]. Rev Med Suisse. 2016 Feb 3;12(504):270-2, 274. French.
PubMed 26999998
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Isotonic Saline as Irrigation Fluid on Serum Electrolytes and Blood Gases in Bipolar Transurethral Resection of Prostate (TUR-P) : A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05285189
- Acronym / sponsor ID
- 2018/1378
- Conditions
- Hyperchloremic Acidosis, Transurethral Resection of Prostate, Normal Anion Gap Metabolic Acidosis, Anesthesia
- Keywords
- Blood gas analysis, TUR-P, Irrigation Fluid, Hyperchloremia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 29 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 17 Mar 2022 (actual)
- 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.
Benign hypertrophy of the prostate (BPH) is a disease seen in 20% of men over the age of 50 and in 40% of those over the age of 70. The gold standard in the treatment of BPH is transurethral resection of the prostate using high-frequency diathermy. Today, this process is done with the bipolar technique, in which isotonic saline (isotonic sodium chloride %0.9) is used as the irrigation fluid. This irrigation fluid, which is used after long operation and deep tissue resection, can enter the systemic circulation through the opened venous sinuses.
It has been shown in clinical studies that postoperative acute hyperchloremia (serum Cl level > 110 mmol/L) develops after the use of intravenous normal saline solution in large amounts in the perioperative period.
Our aim is to detect hyperchloremia and associated metabolic acidosis without anion gap in the follow-up of these patients. Our primary hypothesis in this study is that hyperchloremic metabolic acidosis will develop due to the high amount of normal saline used in TUR-P.
.
Detailed description
Benign hypertrophy of the prostate (BPH) is a disease seen in 20% of men over the age of 50 and in 40% of those over the age of 70. The gold standard in the treatment of BPH is transurethral resection of the prostate using high-frequency diathermy. Today, this process is done with the bipolar technique, in which normal saline (isotonic sodium chloride %0.9) is used as the irrigation fluid. In bipolar TUR-P, resection is performed using 25000 - 30000 ml normal saline for irrigation. This irrigation fluid, which is used after long operation and deep tissue resection, can enter the systemic circulation through the opened venous sinuses.
It has been shown in clinical studies that postoperative acute hyperchloremia (serum Cl level > 110 mmol/L) develops after the use of intravenous normal saline solution in large amounts in the perioperative period. McCluskey et al. found that 30-day mortality, prolonged hospital stay, and postoperative renal dysfunction developed in patients who received perioperative intravenous normal saline and subsequently developed acute hyperchloremia. Megan E. et al. Scheingraber et al. reported that the use of normal saline increases the risk of acidosis and kidney damage, also compared Ringer's lactate and normal saline infusion in patients who underwent gynecological surgery and showed that hyperchloremic metabolic acidosis developed in normal saline group. Excessive and rapid administration of normal saline solution by parenteral route causes hyperchloremic metabolic acidosis, which adversely affects the organism. According to recent studies, the development of hyperchloremic metabolic acidosis increases the cost and mortality, prolongs the hospitalization period, and causes renal dysfunction.
Our aim is to detect hyperchloremia and associated metabolic acidosis without anion gap in the follow-up of these patients. Our primary hypothesis in this study is that hyperchloremic metabolic acidosis will develop due to the high amount of normal saline used in TUR-P.
The investigators expect that an increase in the amount of fluid, prolongation of the operation time, and capsule perforation will increase hyperchloremia and deepen metabolic acidosis. If it causes hyperchloremic metabolic acidosis, the contribution of the amount of irrigation fluid or the duration of the operation can be determined, and the maximum amount of fluid that does not adversely affect the organism and the duration of the operation can be predicted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Male gender who being prostate hyperplasia * Having had a TUR-P operation * Using of bipolar technic * American Society of Anesthesiology (ASA) grade I-III * Receiving patients consent
Key inclusion criteria (5 listed)
- Male gender
- Having had a TUR-P operation
- Using of bipolar technic
- American Society of Anesthesiology (ASA) grade I-III
- Receiving patients consent
Key exclusion criteria (2 listed)
- Failure to record preoperative and postoperative blood gas data
- Patient refusal
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
Serum Chlorid level
Time frame: Up to 4 hours
Chlorid level is evaluated with blood gas analysis 3 times in total, at the beginning of the operation, at the 40th minute of the operation and 1st hour of arrival in post-anesthesia care unit.
11 secondary outcomes
Serum anion gap level
Time frame: Up to 4 hours
Serum lactate level
Time frame: Up to 4 hours
Presence&absence of capsule perforation during the operation
Time frame: Up to 4 hours
Amount of prostate tissue resected during the operation
Time frame: Up to 4 hours
Amount of used normal saline for irrigation during the operation
Time frame: Up to 4 hours
Duration of operation
Time frame: Up to 4 hours
Incidence of postoperative acute kidney injury
Time frame: Up to 48 hours
Incidence of mortality rate
Time frame: Up to 6 months
Length of hospital stay
Time frame: Up to 1 week
Number of participants with urethral stricture
Time frame: Up to 6 months
Number of participants with urinary bladder hematoma
Time frame: Up to 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Results publication: PubMed 25768968Barker ME. 0.9% saline induced hyperchloremic acidosis. J Trauma Nurs. 2015 Mar-Apr;22(2):111-6. doi: 10.1097/JTN.0000000000000115.
- Results publication: PubMed 26999998Dombre V, De Seigneux S, Schiffer E. [Sodium chloride 0.9%: nephrotoxic crystalloid?]. Rev Med Suisse. 2016 Feb 3;12(504):270-2, 274. French.
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.
Meltem Savran Karadeniz, Assoc.Prof. principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperchloremic Acidosis and Transurethral Resection of Prostate, run by Istanbul University at 1 site in Turkey (Türkiye).
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabiha Başarı, MD (+905446616686, sabihabasari0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Chlorid level (time frame: Up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05285189, which also lists 2 linked publications.
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 31 Mar 2022.