Condition category
Signs and Symptoms
Date applied
26/05/2006
Date assigned
13/06/2006
Last edited
05/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Zhi Xun Fang

ORCID ID

Contact details

1-1 Zhong-fu Road
Nanjing
210003
China
+86 025 58802968
fangzhixun@yahoo.com.cn

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TS 9904

Study information

Scientific title

Acronym

ESBRPSS

Study hypothesis

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

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.

Study design

Randomized controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Sodium bicarbonate

Primary outcome measures

Cardiac output (CO) and mean arterial pressure during 8 hours after starting fluid treatment

Secondary outcome measures

1. Respiratory rate, heart rate and temperature
2. Blood gas and electrolyte
3. 28-day mortality

Overall trial start date

01/06/2001

Overall trial end date

31/10/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant 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.

Recruitment start date

01/06/2001

Recruitment end date

31/10/2005

Locations

Countries of recruitment

China

Trial participating centre

1-1 Zhong-fu Road
Nanjing
210003
China

Sponsor information

Organisation

The Second Hospital of Nanjing, affiliated with Medical College, Southeast University (China)

Sponsor details

1-1 Zhong-fu Road
Nanjing
210003
China
+86 025 83466026
yinguoq@jlonline.com

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

The Health Office of Jiangus Provincial Govermment, China

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18419825

Publication citations

  1. Results

    Fang ZX, Li YF, Zhou XQ, Zhang Z, Zhang JS, Xia HM, Xing GP, Shu WP, Shen L, Yin GQ, Effects of resuscitation with crystalloid fluids on cardiac function in patients with severe sepsis., BMC Infect. Dis., 2008, 8, 50, doi: 10.1186/1471-2334-8-50.

Additional files

Editorial Notes