Effects of resuscitation with sodium bicarbonate on cardiac function in patients with early-phase septic shock
| ISRCTN | ISRCTN36748319 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36748319 |
| Protocol serial number | TS 9904 |
| Sponsor | The Second Hospital of Nanjing, affiliated with Medical College, Southeast University (China) |
| Funder | The Health Office of Jiangus Provincial Govermment, China |
- Submission date
- 26/05/2006
- Registration date
- 13/06/2006
- Last edited
- 05/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Zhi Xun Fang
Scientific
Scientific
1-1 Zhong-fu Road
Nanjing
210003
China
| Phone | +86 025 58802968 |
|---|---|
| fangzhixun@yahoo.com.cn |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | ESBRPSS |
| Study objectives | To compare the effects of normal solution, 3.5% hypertonic saline solution and 5% sodium bicarbonate on cardiac output and blood pressure, in patients with early phase septic shock, when given fluid resuscitation |
| Ethics approval(s) | Approved by the Health Office of Jiangsu Provincial Government on 17/03/2000, reference number: TS 9904 and by all the hospital ethical committees namely: Ethics Committee of the Second Hospital of Nanjing on 07/04/2000, reference number: 200001; the Ethics Committee of the First People's Hospital of Huai'an City on 24/10/2000, reference number: 200002; the Ethics Committee of the People's Hospital of Gaochun County on 09/08/2000, reference number: G200001; the Ethics Committee of the First Hospital of Nanjing on 22/03/2001, reference number: 200103 and the Ethics Committee of the Jiangsu Provincial Hospital on 25/03/2001, reference number: 200108. |
| Health condition(s) or problem(s) studied | Cardiac functions in patients with early-phase septic shock |
| Intervention | Subjects are randomly assigned to three groups: 1. The Ns group: patients are injected with 5 ml/kg of normal solution (n = 30) 2. The Hs group (n=30), patients are injected with 5 ml/kg of 3.5% sodium chloride 3. The Sb group (n = 30), patients are injected with 5 ml/kg of 5% sodium bicarbonate within 15 min at initial treatment (T0 min) At 100 min after T0 min, all the patients are injected with 20 ml/kg of 0.9% normal saline. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sodium bicarbonate |
| Primary outcome measure(s) | Cardiac output (CO) and mean arterial pressure during 8 hours after starting fluid treatment |
| Key secondary outcome measure(s) | 1. Respiratory rate, heart rate and temperature 2. Blood gas and electrolyte 3. 28-day mortality |
| Completion date | 31/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 90 |
| Key inclusion criteria | Patents with early phase septic shock (according to the criteria of the American College of Chest Physicians/Society of Critical Care Medicine). The criteria for inclusion is fulfilment of two out of the four criteria for the systemic inflammatory response syndrome (SIRS) and a systolic blood pressure lower than 90 mmHg or a reduction of 40 mm Hg from baseline. |
| Key exclusion criteria | Patients with a myocardial infarction, hemorrhagic shock, trauma, pregnancy, do-not-attempt-resuscitation orders, or immediate surgery requirement are excluded. In order to focus the study on the subject of early phase septic shock, the patients with last-phase septic shock characterized by coma, seizure, diffusing intravascular coagulation (DIC), pulmonary edema and anuria on admission were rejected. The cases treated with vasopressors, inotropic agents and mechanical ventilation during the initial two hours or with death imminent within 24 hours were also rejected. |
| Date of first enrolment | 01/06/2001 |
| Date of final enrolment | 31/10/2005 |
Locations
Countries of recruitment
- China
Study participating centre
1-1 Zhong-fu Road
Nanjing
210003
China
210003
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/04/2008 | Yes | No |
