Acid-Base ImbalanceNCT03496311
Cerebrospinal Acid-base in Pregnant and Non-pregnant Fertile Women
An observational study of Acid-Base Imbalance and Respiratory Alkalosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The third trimester of pregnancy is typically characterized by the development of a marked respiratory alkalosis. The possible role of pregnancy-induced variations of cerebrospinal fluid (CSF) acid-base characteristics on the development of hypocapnic alkalosis is still unknown. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Acid-Base Imbalance, Respiratory Alkalosis, Cerebrospinal Fluid
- What is being tested?
- Acid - Base characterization
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 13 Apr 2018to Apr 2019
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women undergoing spinal anesthesia either for elective cesarean section of for elective surgery.
Who may be able to join
- Pregnancy with gestational age > 35 weeks
- Scheduled elective cesarean section under spinal anesthesia
Who cannot join
- known respiratory or neurologic disease
- multiple pregnancies
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
Thomas Langer, MD, thomas.langer@unimi.it
About this study
Official title: Effects of Pregnancy on the Physico-chemical Characteristics of Cerebrospinal Acid-base Equilibrium
The third trimester of pregnancy is typically characterized by the development of a marked respiratory alkalosis. The possible role of pregnancy-induced variations of cerebrospinal fluid (CSF) acid-base characteristics on the development of hypocapnic alkalosis is still unknown.
Aim of this study is to characterize, according to Stewart's approach, the acid-base equilibrium of CSF and arterial plasma of pregnant women and compare the results with data obtained from fertile, non-pregnant women.
Read the detailed description
The reduction in plasma PCO2 correlates with gestational age and was shown to be associated to plasma progesterone concentrations. We hypothesize that pregnancy-related haemodilution, inducing a reduction in CSF Strong Ion Difference (SID), might have a role in the development of pregnancy-related hypocapnic alkalosis.
Samples of CSF and arterial plasma of pregnant women with gestational age > 35 weeks undergoing spinal anesthesia for elective caesarean section will be analyzed for blood gases, pH, electrolytes, osmolality, albumin and haemoglobin concentration. In addition plasma copeptin levels will be analyzed. The same measurements will be performed in fertile, non-pregnant women undergoing spinal anesthesia for elective surgery.
- Being tested
- Acid - Base characterization
- Medical subject headings
- Acid-Base Imbalance, Alkalosis, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acid - Base characterizationDiagnostic test
Samples of cerebrospinal fluid and arterial blood will be collected anaerobically to measure acid-base variables, electrolytes, albumin, progesterone and copeptin levels
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women | Pregnant women with gestational age > 35 weeks undergoing spinal anesthesia for elective cesarean section. Receives: Diagnostic Test: Acid - Base characterization | |
| Control Group | Fertile, non-pregnant women undergoing spinal anesthesia for elective surgery. Receives: Diagnostic Test: Acid - Base characterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strong Ion Difference
Strong Ion Difference (expressed in milliequivalents per Liter [mEq/L]) of cerebrospinal fluid and arterial plasma
Measured: 1 day
Secondary outcomes (6)
Partial pressure of carbon dioxide (PCO2)
PCO2 (expressed in millimeters of Mercury [mmHg]) of cerebrospinal fluid and arterial plasma
Measured: 1 day
Sum of albumin (expressed in mmol/L) and Phosphates (expressed in mmol/L)
The total amount of weak non carbonic acids, i.e. the sum of albumin and phosphates (both expressed in mmol/L) of cerebrospinal fluid and arterial plasma
Measured: 1 day
Difference between cerebrospinal fluid and arterial plasma Strong Ion Difference (Delta SID)
The difference between plasma and cerebrospinal fluid SID (expressed in mEq/L) will be calculated as marker of electrolyte inbalance between these two extracellular fluid compartments. Delta SID = SIDcsf - SIDplasma
Measured: 1 day
Difference between cerebrospinal fluid and arterial plasma partial pressure of CO2 (Delta PCO2)
The difference between cerebrospinal fluid and arterial plasma PCO2 (expressed in mmHg) will be calculated as a marker of acid-base equilibrium between these two extracellular fluid compartments. Delta PCO2 = SIDplasma - SIDcsf
Measured: 1 day
Progesterone levels
Plasma and CSF Progesterone levels (expressed in ng/mL) will be measured
Measured: 1 day
Copeptin levels
Plasma copeptin levels (expressed in pmol/L) will be measured as a marker of antidiuretic hormone activity
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start13 Apr 2018
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acid-Base ImbalanceStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan
- Responsible party
- Sponsor
- Investigators
- Thomas Langer, MD, Principal investigator, University of MilanAntonio Pesenti, MD, Study director, University of MilanEdoardo Calderini, MD, Study chair, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di MilanoGiorgio Giudici, MD, Study chair, University of MilanMariateresa Ambrosini, MD, Study chair, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496311
- Sponsor's protocol ID
- CSF acid-base in pregnancy
- Status last verified
- Apr 2018
- First submitted
- 29 Mar 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zadek F, Giudici G, Ferraris Fusarini C, Ambrosini MT, di Modugno A, Scaravilli V, Zanella A, Fumagalli R, Stocchetti N, Calderini E, Langer T. Cerebrospinal fluid and arterial acid-base equilibria in spontaneously breathing third-trimester pregnant women. Br J Anaesth. 2022 Nov;129(5):726-733. doi: 10.1016/j.bja.2022.07.048. Epub 2022 Sep 10.
PubMed 36096944
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pregnancy on the Physico-chemical Characteristics of Cerebrospinal Acid-base Equilibrium
- ClinicalTrials.gov ID
- NCT03496311
- Acronym / sponsor ID
- CSF acid-base in pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- University of Milan
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 12 Apr 2018 (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.
The third trimester of pregnancy is typically characterized by the development of a marked respiratory alkalosis. The possible role of pregnancy-induced variations of cerebrospinal fluid (CSF) acid-base characteristics on the development of hypocapnic alkalosis is still unknown.
Aim of this study is to characterize, according to Stewart's approach, the acid-base equilibrium of CSF and arterial plasma of pregnant women and compare the results with data obtained from fertile, non-pregnant women.
Detailed description
The reduction in plasma PCO2 correlates with gestational age and was shown to be associated to plasma progesterone concentrations. We hypothesize that pregnancy-related haemodilution, inducing a reduction in CSF Strong Ion Difference (SID), might have a role in the development of pregnancy-related hypocapnic alkalosis.
Samples of CSF and arterial plasma of pregnant women with gestational age > 35 weeks undergoing spinal anesthesia for elective caesarean section will be analyzed for blood gases, pH, electrolytes, osmolality, albumin and haemoglobin concentration. In addition plasma copeptin levels will be analyzed. The same measurements will be performed in fertile, non-pregnant women undergoing spinal anesthesia for elective surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | Diagnostic Test: Acid - Base characterizationPregnant women with gestational age > 35 weeks undergoing spinal anesthesia for elective cesarean section. |
| Control Group | – | Diagnostic Test: Acid - Base characterizationFertile, non-pregnant women undergoing spinal anesthesia for elective surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing spinal anesthesia either for elective cesarean section of for elective surgery.
Key inclusion criteria (2 listed)
- Pregnancy with gestational age > 35 weeks
- Scheduled elective cesarean section under spinal anesthesia
Key exclusion criteria (2 listed)
- known respiratory or neurologic disease
- multiple pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acid - Base characterizationSamples of cerebrospinal fluid and arterial blood will be collected anaerobically to measure acid-base variables, electrolytes, albumin, progesterone and copeptin levels | Diagnostic test | Control Group, Pregnant Women |
Primary outcome
Strong Ion Difference
Time frame: 1 day
Strong Ion Difference (expressed in milliequivalents per Liter [mEq/L]) of cerebrospinal fluid and arterial plasma
6 secondary outcomes
Partial pressure of carbon dioxide (PCO2)
Time frame: 1 day
Sum of albumin (expressed in mmol/L) and Phosphates (expressed in mmol/L)
Time frame: 1 day
Difference between cerebrospinal fluid and arterial plasma Strong Ion Difference (Delta SID)
Time frame: 1 day
Difference between cerebrospinal fluid and arterial plasma partial pressure of CO2 (Delta PCO2)
Time frame: 1 day
Progesterone levels
Time frame: 1 day
Copeptin levels
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Derived from this study: PubMed 36096944Zadek F, Giudici G, Ferraris Fusarini C, Ambrosini MT, di Modugno A, Scaravilli V, Zanella A, Fumagalli R, Stocchetti N, Calderini E, Langer T. Cerebrospinal fluid and arterial acid-base equilibria in spontaneously breathing third-trimester pregnant women. Br J Anaesth. 2022 Nov;129(5):726-733. doi: 10.1016/j.bja.2022.07.048. Epub 2022 Sep 10.
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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.
Thomas Langer, MD principal investigator
University of Milan
Antonio Pesenti, MD study director
University of Milan
Edoardo Calderini, MD study chair
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
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 Acid-Base Imbalance and Respiratory Alkalosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 2 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 17 Apr 2018. 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 Italy. 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 Thomas Langer, MD (+390250320463, thomas.langer@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strong Ion Difference (time frame: 1 day). 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 NCT03496311, which also lists 1 linked publication.
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 17 Apr 2018.