Anesthesia; Adverse Effect, Spinal and EpiduralPhase 4NCT02393196
Colloid Preload Versus Colloid Coload During Cesarean Deliveries
A Phase 4 study testing hydroxyethyl starch (% 6 HES 130/0.4) (Voluven®) and hydroxyethyl starch (%6 HES 130/0.4) (Voluven®) in people with Anesthesia; Adverse Effect, Spinal and Epidural and Hypotension, run by Sifa University at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to compare the methods colloid preloading and colloid coloading in terms of the incidence of maternal hypotension and impacts on neonatal outcomes. The second aim while planning the present study is to identify the method of the lowest adverse event for mother and infant and the simplest… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia; Adverse Effect, Spinal and Epidural, Hypotension
- What is being tested?
- hydroxyethyl starch (% 6 HES 130/0.4) (Voluven®) and hydroxyethyl starch (%6 HES 130/0.4) (Voluven®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2015to Mar 2016
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Singleton pregnancy
- Gestational age ≥ 37 weeks
- Height ≥ 150 cm and ≤ 180 cm
- Weight > 50 kg and < 100 kg
Who cannot join
- Gestational age > 37 weeks
- Multiple pregnancies
- Fetal distress
- Preeclampsia
- Cardiovascular disease and diabetes
- Hematological problems
Show all 12Show fewer
- Local infection at intervention site
- Abnormal coagulation tests
- Anticoagulant use
- Starch allergy
- Height < 150 cm and > 180 cm
- Weight < 50 kg and > 100 kg
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Şifa Üniversitesi, Basmane Hastanesi
Izmir, 35100
About this study
Official title: Colloid Preload Versus Colloid Coload in Preventing Spinal Anesthesia-Induced Hypotension During Cesarean Section Deliveries: A Prospective, Randomized, Double-Blind Comparative Study
The investigators aimed to compare the methods colloid preloading and colloid coloading in terms of the incidence of maternal hypotension and impacts on neonatal outcomes. The second aim while planning the present study is to identify the method of the lowest adverse event for mother and infant and the simplest approach for the clinician.
Read the detailed description
Spinal anesthesia (SA) is currently the most preferred method of anesthesia in elective cesarean deliveries. However, SA causes maternal hypotension by decreasing systemic vascular resistance over sympathetic blockade. Maternal hypotension can lead to serious adverse events both in mother and in fetus: fetal hypoxia and acidosis occur due to decreased uterine blood flow, whereas the mother may experience vertigo, nausea, vomiting, alteration in consciousness, cardiovascular collapse and arrest. Today, various strategies have been suggested for the prevention of maternal hypotension. Of these strategies, the most critical ones are fluid load before spinal anesthesia (preloading) or rapid fluid load just after spinal anesthesia (coloading) and the use of vasopressor agent. The fluids used for this purpose include crystalloids and colloids. Comparative studies performed with colloid preloading, colloid coloading and crystalloid coloading indicated that the incidence of hypotension decreased similarly with no significant difference determined between the methods of fluid loading. Researchers defended necessity of using vasopressor agent together with fluid loading methods. In daily routine; however, the investigators observe that the incidence of hypotension is lower in the patients that undergo colloid preloading as compared to the patients that undergo colloid coloading or crystalloid coloading. The investigators therefore aimed to compare the methods colloid preloading and colloid coloading in terms of the incidence of maternal hypotension and impacts on neonatal outcomes. In the present study, the investigators aimed to use 6% HES 130/0.4 (Voluven ®), which is the newer generation colloid solution. The other aim while planning the present study is to identify the method of the lowest adverse event for mother and infant and the simplest approach for the clinician.
- Being tested
- hydroxyethyl starch (% 6 HES 130/0.4) (Voluven®), hydroxyethyl starch (%6 HES 130/0.4) (Voluven®)
- Keywords
- colloid preloading, colloid coloading
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydroxyethyl starch (% 6 HES 130/0.4) (Voluven®)Drug
Also called (Voluven®; Fresenius Kabi, Bad Homburg, Germany)
Before spinal anesthesia
hydroxyethyl starch (%6 HES 130/0.4) (Voluven®)Drug
Also called (Voluven®; Fresenius Kabi, Bad Homburg, Germany)
Just after spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group Preloading (Group P) | Active comparator | Group Preloading (Group P): 500 mL hydroxyethyl starch (6% HES 130/0.4) (Voluven®; Fresenius Kabi, Bad Homburg, Germany) will be infused via a pressure infusion system at a maximum speed as possible before spinal anesthesia. Receives: Drug: hydroxyethyl starch (% 6 HES 130/0.4) (Voluven®) |
| Group Coloading (Group C) | Active comparator | Group Coloading (Group C): After the patients have been monitored, spinal anesthesia will be performed. Recognizing the cerebrospinal fluid, 500 mL hydroxyethyl starch (%6 HES 130/0.4) (Voluven®; Fresenius Kabi, Bad Homburg, Germany) will be infused via a pressure infusion system at a maximum speed as possible. Receives: Drug: hydroxyethyl starch (%6 HES 130/0.4) (Voluven®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal hypotension.
Maternal hypotension will be defined as at least a single administration of ephedrine within the period from induction of SA to the delivery (umbilical cord clamping). After spinal anesthesia, SAP will be measured and recorded at every minute until birth and every three minutes thereafter.
Measured: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Incidence of severe hypotension.
Incidence of severe hypotension (SAP < 70% of the baseline value or SAP < 80 mmHg) will be recorded.
Measured: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Cumulative duration of hypotension.
Cumulative duration of hypotension will be recorded from induction of spinal anesthesia until delivery (umbilical cord clamping).
Measured: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Heart rate.
Minimum and maximum heart rate, bradycardia, atropine usage will be recorded.
Measured: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Secondary outcomes (3)
Neonatal effects.
Arterial and venous blood gas analyses will be performed from the umbilical cord after the cord clamped.
Measured: Time just after delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Ephedrine treatment.
If SAB < 100 mmHg; patients will be treated by 5 mg IV bolus ephedrine, if SAB < 90 mmHg; patients will be treated by 10 mg IV bolus ephedrine.
Measured: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Nausea and/or vomiting.
Incidence of nausea and/or vomiting, incidence of prepartum nausea and/or vomiting will be recorded.
Measured: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; Adverse Effect, Spinal and EpiduralStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sifa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysun Afife Kar, Sifa University
- Investigators
- Aysun Afife Kar, MD, Principal investigator, Şifa Üniversitesi, Basmane Hastanesi, İzmir, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393196
- Sponsor's protocol ID
- SifaU
- Status last verified
- Nov 2015
- First submitted
- 1 Mar 2015
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colloid Preload Versus Colloid Coload in Preventing Spinal Anesthesia-Induced Hypotension During Cesarean Section Deliveries: A Prospective, Randomized, Double-Blind Comparative Study
- ClinicalTrials.gov ID
- NCT02393196
- Acronym / sponsor ID
- SifaU
- Keywords
- colloid preloading, colloid coloading
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sifa UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 19 Mar 2015 (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.
The investigators aimed to compare the methods colloid preloading and colloid coloading in terms of the incidence of maternal hypotension and impacts on neonatal outcomes. The second aim while planning the present study is to identify the method of the lowest adverse event for mother and infant and the simplest approach for the clinician.
Detailed description
Spinal anesthesia (SA) is currently the most preferred method of anesthesia in elective cesarean deliveries. However, SA causes maternal hypotension by decreasing systemic vascular resistance over sympathetic blockade. Maternal hypotension can lead to serious adverse events both in mother and in fetus: fetal hypoxia and acidosis occur due to decreased uterine blood flow, whereas the mother may experience vertigo, nausea, vomiting, alteration in consciousness, cardiovascular collapse and arrest. Today, various strategies have been suggested for the prevention of maternal hypotension. Of these strategies, the most critical ones are fluid load before spinal anesthesia (preloading) or rapid fluid load just after spinal anesthesia (coloading) and the use of vasopressor agent. The fluids used for this purpose include crystalloids and colloids. Comparative studies performed with colloid preloading, colloid coloading and crystalloid coloading indicated that the incidence of hypotension decreased similarly with no significant difference determined between the methods of fluid loading. Researchers defended necessity of using vasopressor agent together with fluid loading methods. In daily routine; however, the investigators observe that the incidence of hypotension is lower in the patients that undergo colloid preloading as compared to the patients that undergo colloid coloading or crystalloid coloading. The investigators therefore aimed to compare the methods colloid preloading and colloid coloading in terms of the incidence of maternal hypotension and impacts on neonatal outcomes. In the present study, the investigators aimed to use 6% HES 130/0.4 (Voluven ®), which is the newer generation colloid solution. The other aim while planning the present study is to identify the method of the lowest adverse event for mother and infant and the simplest approach for the clinician.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Preloading (Group P) | Active comparator | Drug: hydroxyethyl starch (% 6 HES 130/0.4) (Voluven®)Group Preloading (Group P): 500 mL hydroxyethyl starch (6% HES 130/0.4) (Voluven®; Fresenius Kabi, Bad Homburg, Germany) will be infused via a pressure infusion system at a maximum speed as possible before spinal anesthesia. |
| Group Coloading (Group C) | Active comparator | Drug: hydroxyethyl starch (%6 HES 130/0.4) (Voluven®)Group Coloading (Group C): After the patients have been monitored, spinal anesthesia will be performed. Recognizing the cerebrospinal fluid, 500 mL hydroxyethyl starch (%6 HES 130/0.4) (Voluven®; Fresenius Kabi, Bad Homburg, Germany) will be infused via a pressure infusion system at a maximum speed as possible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Singleton pregnancy
- Gestational age ≥ 37 weeks
- Height ≥ 150 cm and ≤ 180 cm
- Weight > 50 kg and < 100 kg
Key exclusion criteria (12 listed)
- Gestational age > 37 weeks
- Multiple pregnancies
- Fetal distress
- Preeclampsia
- Cardiovascular disease and diabetes
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 |
|---|---|---|
| hydroxyethyl starch (% 6 HES 130/0.4) (Voluven®)Also: (Voluven®; Fresenius Kabi, Bad Homburg, Germany)Before spinal anesthesia | Drug | Group Preloading (Group P) |
| hydroxyethyl starch (%6 HES 130/0.4) (Voluven®)Also: (Voluven®; Fresenius Kabi, Bad Homburg, Germany)Just after spinal anesthesia | Drug | Group Coloading (Group C) |
Primary outcome
Maternal hypotension.
Time frame: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Maternal hypotension will be defined as at least a single administration of ephedrine within the period from induction of SA to the delivery (umbilical cord clamping). After spinal anesthesia, SAP will be measured and recorded at every minute until birth and every three minutes thereafter.
Incidence of severe hypotension.
Time frame: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Incidence of severe hypotension (SAP < 70% of the baseline value or SAP < 80 mmHg) will be recorded.
Cumulative duration of hypotension.
Time frame: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Cumulative duration of hypotension will be recorded from induction of spinal anesthesia until delivery (umbilical cord clamping).
Heart rate.
Time frame: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Minimum and maximum heart rate, bradycardia, atropine usage will be recorded.
3 secondary outcomes
Neonatal effects.
Time frame: Time just after delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Ephedrine treatment.
Time frame: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Nausea and/or vomiting.
Time frame: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 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.
Aysun Afife Kar, MD principal investigator
Şifa Üniversitesi, Basmane Hastanesi, İzmir, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hydroxyethyl starch (% 6 HES 130/0.4) (Voluven®) and hydroxyethyl starch (%6 HES 130/0.4) (Voluven®) in people with Anesthesia; Adverse Effect, Spinal and Epidural and Hypotension, run by Sifa 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 12 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 Nov 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Aysun Afife Kar, MD (+905326521313, aaysunkar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal hypotension. (time frame: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 17 Nov 2015.